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Straumann® Anatomic Healing Abutments are indicated to be placed in partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.

The Straumann Anatomic Healing Abutments XC (referred to as the AHAs) are intended for use with the Straumann Dental Implant System (SDIS). The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the osseointegration phase of Straumann endosseous dental implants to be rehabilitated using the delayed loading technique. The AHA are to be used during the implant placement surgery or in the reopening surgery (second surgical phase) and are for temporary use up to 180 days. The AHAs are to be placed out of occlusion. The healing abutments do not support a prosthetic restoration.

The AHAs are composed of two united parts: a body that allows for customization and includes a through hole for fixation screw access, and a basal screw that cannot be altered. The Anatomic Healing Abutments are intended to be customized using only hand milling instruments manually controlled by dental professionals. To protect the consistent emergence profile for final abutment, a maximum 3mm height can be modified down to the occlusal surface. To preserve the scanning function of AHA, a 4.7mm circular area around the central axis of the screw channel cannot be modified. The body is milled from polyetheretherketone (PEEK Classix). The basal screws are existing basal screws manufactured from Titanium-Aluminum-Niobium (TAN) alloy previously cleared as part of the Straumann BLX system in K173961.

The AHA are designed for connection to BLC and BLX implants of the Straumann Dental Implant System (K173961, K181703, K191256, K210855, K212533, K230108, and K234049). The AHA are available in diameters of Ø3.8 mm, 4.5mm, 5.5mm, and 6.5mm. They are available in 4 shapes designed according to specific areas of the dentition including S, S1, M, and XL, however, they are not limited to use exclusively in these positions. The AHA are offered in regular base (RB) and wide base (WB) configurations consistent with the Straumann BLX and BLC prosthetic platform offerings.

The AHAs may also be used in intraoral scanning procedures of single-unit restorations to represent the position, axis, and orientation of the dental implant placed in the patient's jaw relative to the surrounding dentition. A scanbody feature extends from the occlusal surface of the AHA.

The provided text is a 510(k) summary for the Straumann Anatomic Healing Abutments XC (AHA). It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain the detailed acceptance criteria or a study designed to prove the device meets specific performance criteria in the format typically used for AI/software-based medical devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing legally marketed devices through comparisons of technological characteristics, intended use, and various performance tests (sterilization, shelf life, biocompatibility, torque, and basic software verification) that confirm the new device functions as expected for a medical device of its class, rather than proving specific numerical performance metrics against defined acceptance criteria in a clinical setting.

Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.

Here is what can be extracted and inferred from the document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit, quantifiable acceptance criteria with corresponding performance results are not provided in the document for the device itself (Straumann® Anatomic Healing Abutments XC). The document focuses on demonstrating substantial equivalence to predicate devices through various tests rather than meeting numerical performance thresholds for image analysis or diagnostic accuracy.

The performance tests mentioned are:

• Sterilization Validation and Shelf Life:
  • Acceptance Criteria (inferred): Sterility Assurance Level (SAL) of 10^-6 for gamma irradiation and successful steam sterilization validation. Packaging stability for a 5-year shelf life.
  • Reported Performance: Met SAL of 10^-6 using VDmax25 in accordance with ISO 11137-1:2006. Steam sterilization validation met all test method acceptance criteria. Packaging stability for the 5-year shelf life of predicate devices was adopted.
• Pyrogen Testing (LAL test):
  • Acceptance Criteria (inferred): Pyrogen limit specification of 20 endotoxin units (EU)/device.
  • Reported Performance: Met the specified limit.
• Biocompatibility Testing:
  • Acceptance Criteria (inferred): No cytotoxic reaction, no extractable substances above Analytical Evaluation Threshold (AET).
  • Reported Performance: No cytotoxic reaction detected. No extractable substances detected above AET.
• Performance Testing - Bench (Torque Testing):
  • Acceptance Criteria (inferred): Withstands repeated insertion and removal torques without damage.
  • Reported Performance: Performed, demonstrating the AHA withstands repeated insertion and removal torques without damage. (Specific numerical thresholds not provided).
• Software Testing (Scan Verification and Integration):
  • Acceptance Criteria (inferred): Can be scanned with an intraoral scanner and is suitable to work with CARES Visual software.
  • Reported Performance: Performed, demonstrating the subject AHAs can be scanned with an intraoral scanner and are suitable to work with CARES Visual software. (No specific metrics provided).

2. Sample size used for the test set and the data provenance

• The document describes engineering tests (sterilization validation, mechanical torque testing, biocompatibility, software verification) rather than a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of this 510(k) for a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is not a study involving expert-derived ground truth on a clinical dataset for AI/software performance.

4. Adjudication method for the test set

• Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This is a physical medical device (healing abutment), not an AI/software for diagnostic assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the engineering tests:
  • Sterilization/Pyrogenicity: Laboratory test results against validated standards and specified limits.
  • Biocompatibility: Laboratory test results against ISO standards and AET.
  • Torque Testing: Mechanical testing results against functional requirements (withstanding torque without damage).
  • Software Testing: Functional verification (can be scanned, works with software).

8. The sample size for the training set

• Not applicable, as this is a physical device and not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established

• Not applicable.

Summary of what the document implies about meeting criteria:

The document asserts that the Straumann® Anatomic Healing Abutments XC (AHA) meet the necessary performance criteria through a series of benchtop engineering tests and validations designed to demonstrate:

• Effective sterilization (gamma irradiation and steam sterilization).
• Pyrogenicity within acceptable limits.
• Biocompatibility of the materials.
• Mechanical integrity (torque resistance).
• Compatibility with intraoral scanning and associated software.

The primary "study" presented is a comparison to predicate devices to establish substantial equivalence based on similar technological characteristics and performance testing. The "acceptance criteria" are implicitly met by successful completion of these validation tests against established industry standards (e.g., ISO) and functional requirements, rather than through a clinical study with statistical performance metrics against a defined ground truth.

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The Straumann Cassettes are used to organize, sterilize and transport surgical instruments and auxiliaries between and during surgical uses. They are indicated to be used in healthcare facilities by healthcare professionals.

The Straumann Cassettes are to be enclosed in FDA cleared sterilization pouches in two layers to maintain the sterility of the enclosed devices using the following sterilization parameters: pre-vacuum steam exposure at 132°C (270° F) for 4 minutes, 30 minutes drying time.

The Straumann Cassettes have been validated for a maximum load of 1005 grams for the Surgical Cassettes, 2007 grams for the Osteotome Cassettes, 283 grams for the Bone Block Fixation Cassette and 65 grams for the Screw Container, including cassette and instruments.

Straumann® Surgical Cassettes are designed to hold various dental surgical drills and tools in order to organize, sterilize and protect the instruments that are sterilized by the healthcare provider. The subject devices consist of reusable rigid containers, comprising of a case bottom (base), a removable inner tray base (tray), and tray lid (lid). The case base, tray base, and tray lid are designed to be integrated into a single unit which contains and protects the interior components during sterilization and subsequent storage. The tray lid latches to the case bottom is designed to secure the kit into a single unit. The kits are perforated to allow for penetration of the moist heat (steam) sterilant and require the use of an FDA-cleared wrap to maintain sterility. To facilitate the surgical procedure and the correct use and positioning of the instruments, the trays and modules have instrument pictograms and/ or color-coded workflows printed on the surface. Surgical and prosthetic instruments of the Straumann® Dental Implant System intended to be placed in the Straumann® Surgical Cassettes are used for bed preparation, placement, maintenance and explanation of the implants from Straumann® Dental Implant System. These devices are all Class I exempt as described in 21 CFR 872.3980 (Endosseous dental implant accessories) and are not subject devices of this submission.

In addition, the Straumann Screw Container is included in this submission. The Straumann Screw Container is used for storing and sterilizing closure screws and healing caps. All the closure screws and healing caps that may be contained in the Screw Container are cleared Class II devices according to 21 CFR 872.3630 (Endosseous dental implant abutment) and are not subject devices of this submission.

The provided document describes the acceptance criteria and the performance testing for the Straumann® Surgical Cassettes, which are used to organize, sterilize, and transport surgical instruments.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document states: "The worst-case cassettes were tested for performance based on critical impact factors including weight, vent to volume ratio and worst-case instruments to be contained."
• It also mentions "Test samples must withstand 100 cycles of use". This indicates that at least one "worst-case" sample was subjected to repeated testing for the life cycle validation.
• Specific numerical sample sizes for each test (e.g., number of cassettes for cleaning validation, or number of sterilization runs) are not provided in the excerpt.
• Data provenance (country of origin, retrospective/prospective) is not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable to this type of device and study. The "ground truth" for these performance tests is based on established scientific and regulatory standards (e.g., ISO, AAMI standards) and objective measurements of sterilization, cleaning efficacy, and material biocompatibility, rather than expert consensus on interpretive tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This information is not applicable as the evaluation of device performance in these tests is based on objective measurements against defined criteria, not on subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• This information is not applicable. The device is not an AI-powered diagnostic or assistive tool for human readers. It is a physical medical device (sterilization cassette).

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• This information is not applicable as the device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for the performance testing is based on objective measurements against established scientific and regulatory standards. For example:
  • Cleaning efficacy: Measured levels of protein and hemoglobin, and visual inspection for soil, compared against quantitative thresholds.
  • Sterilization: Sterility Assurance Level (SAL) of ≤10⁻⁶ using biological indicators, which is a quantitative measure of microbial inactivation.
  • Biocompatibility: Cell viability percentage (>70%) compared against a quantitative threshold in cytotoxicity testing.
  • Life cycle: Functional integrity after a specified number of cycles, assessed objectively.

8. The sample size for the training set:

• This information is not applicable as the device is not an AI algorithm that requires a training set. The performance testing validates the physical characteristics and reprocessing effectiveness of the cassettes.

9. How the ground truth for the training set was established:

• This information is not applicable as the device is not an AI algorithm.

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Straumann® 4 mm Short Implants are intended for oral endosteal implantation in the jaw and for the functional oral rehabilitation of edentulous and partially edentulous patients.

Straumann® 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone and with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. The 4 mm Short Implants are specifically recommended for:

• Fixed partial dentures/splinted units (one implant per unit)
• Pontic cases in combination with at least one longer implant
• Fully edentulous cases with at least one 4 mm Short Implant in combination with 2 longer implants in the anterior region and at least four total implants

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. Straumann® Roxolid® dental implants are solid screw implants comprised of a titanium-zirconium alloy with the hydrophilic SLActive® bone anchorage surface that is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

This premarket notification serves to add new dental implants to the Straumann Dental Implant System portfolio that are 4 mm in length. Other than the implant length, the subject devices are physically identical to the primary predicate tissue level devices except for the implant thread which is identical to the bone level primary predicate devices cleared under K130222.

The Straumann® 4 mm Short Implants are manufactured from the Roxolid® material with the SLActive® surface and are available in Ø4.1 mm with a Regular Neck (RN) Tissue Level implant/abutment interface and in Ø4.8 mm with an RN or Wide Neck (WN) Tissue Level implant/abutment interface.

The provided text does NOT describe an AI/ML powered device, therefore, the requested information elements related to AI/ML device performance and testing (such as AI assistance effect size, ground truth for training/test sets, sample sizes for training/test sets, adjudication methods, and expert qualifications) cannot be extracted or fulfilled.

The document pertains to the 510(k) summary for Straumann® 4 mm Short Implants, a medical device, and the evaluation details focus on the physical and mechanical performance of the implant, biocompatibility, sterilization, and clinical literature review of implant survival rates, not on an AI system's performance.

Therefore, the table of acceptance criteria and reported device performance, and the other requested information points are not applicable in the context of an AI/ML device. The document describes a dental implant, not an AI or imaging device.

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Straumann abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges, and overdentures.

The Straumann prosthetic line consist of abutments which are used for the restoration of Straumann dental implants of different types, endosteal diameters, lengths and platforms. They are available in a variety of shapes and sizes to fit individual patient needs.

The Straumann BLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by mean of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). The screw channel is protected during the lab procedure with a modeling aid made of Polyoxymethylene (POM) which is friction fit to the Ceramicor® alloy base. The modeling aid is a burn-out sleeve for casting and the combination of base and modeling aid is designed to be used together with Straumann BLX Implants having the TorcFit™, conical connection.

The provided text is a 510(k) summary for a medical device (Straumann® BLX Gold Abutments) and does not describe an AI medical device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria, study details for AI performance, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for an AI system.

The document focuses on demonstrating substantial equivalence to predicate devices through material comparison, biocompatibility, sterilization validation, and bench testing for mechanical properties (dynamic fatigue, static strength, and loosening torque).

Here's an overview of the "acceptance criteria" and "study" information that is present, pertaining to a traditional medical device, not an AI one:

Acceptance Criteria and Reported Device Performance (as relevant for a traditional medical device)

Missing Information (as it pertains to an AI medical device, which this is not):

1. Sample sizes for test set and data provenance: No test set as described for an AI model.
2. Number of experts and qualifications to establish ground truth: Not applicable for this type of device.
3. Adjudication method for the test set: Not applicable.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
5. Stand-alone (algorithm only) performance study: Not applicable.
6. Type of ground truth used: Not applicable.
7. Sample size for training set: Not applicable.
8. How ground truth for training set was established: Not applicable.

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Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated.

Temporary Abutments have a maximum duration of usage of 180 days.

The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.

The provided text is a 510(k) summary for Straumann® Screw-Retained Abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance data, mainly bench testing and biocompatibility assessments. It explicitly states that no device-specific clinical data has been submitted.

Therefore, the information required to describe acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study or performance metrics typical for AI devices (like sensitivity, specificity, AUC), is not present in this document.

This document describes a traditional medical device (dental implants and abutments) cleared via the 510(k) pathway, which fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies or AI algorithm validation.

To address the user's request, I must state that the information is not available in the provided document, as it pertains to a different type of device and regulatory submission pathway.

Specifically, the document states:

• "No device specific clinical data has been submitted to demonstrate substantial equivalence." (Page 12, Section 5.7.4)

Here's an explanation with respect to the user's request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence through comparison with predicates, not on meeting predefined performance metrics from a study in the way an AI/software device would. The "performance data" refers to bench testing (dynamic fatigue, static strength, torque) and biocompatibility, which are compared to predicate devices rather than against specific numerical acceptance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no clinical study (with test sets of patient data) was conducted or submitted. The 'samples' referred to in bench testing are physical abutment components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data involving human perception (like AI for image analysis) is not relevant here as no such clinical study was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI-powered device with a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary for Straumann® Screw-Retained Abutments does not contain the type of AI/clinical performance study information requested. The device is a traditional medical device (dental implant components) and its clearance is based on substantial equivalence to predicate devices, verified through bench testing and biocompatibility assessments, not through human reader studies or AI algorithm performance evaluations on clinical datasets.

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ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited ( minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITT 4.1mm dental implant.
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the healing phase and helps stabilize and maintain the soft tissue.
The ITI synOcta angled abutments for Wide Neck Implants are in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge.
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.
The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations.
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed.
The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended after orthodontic treatment has been completed.
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant.
Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.
The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the healing process for us to six months and should be placed out of occlusion.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns. bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained or directly veneered.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability; small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 0 4.8 mm and WN (Wide Neck) 0 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants. The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Straumann® dental implants are suitable for the treatment of oral and endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
The Strauman® CARES® Screw-retained Bridge Titanium and Strauman® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide Neck (WN) 06.5mm) in the treatment of partially edentulous jaws for the purpose of restoring chewing function. The Strauman® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Strauman® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetions such as crowns, bridges and overdentures.
The Strauman® CARES® Variobase ™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase TM Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase TM Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. The Strauman® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase TM Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
Straumann® dental Implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental Implants can also be used for Immediate or early Implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the Implants by the corresponding elements (abutments). When placing in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Closure Screws, healing caps, and healing abutments, are Intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the Implant and maintain, stabilize and form the healing process. Customizable healing abutments made of PEEK are for use for up to six months.
The Straumann Variobase,. Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase. Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw retained restorations.
The Strauman® Magellan TM abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan™ abutments are indicated for screw-retained restorations.
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations.
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements).
The Strauman® Screw Retained Abutments are indicated to be placed into the implants of the Strauman® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw-Retained Abutments are indicated for screw-retained restorations.
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
Straumann dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentuly dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth, Implants can be placed with immediate function on single-tooth and /or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cementretained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments).
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
Straumann® Bone Level Tapered Implants ②2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ②2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobas® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Straumann Screw retained Abutments are indicated to be placed into the implants of the Straumann Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann Screw Retained Abutments are indicated for screw-retained restorations.
This abutment system is intended to be used in conjunction with ITI endosseous dental implants to provide support for prosthetic devices (crowns, bridges, overdentures) for the functional and oral rehabilitation of edentulous or partially edentulous patients.
The Memfix Screws are intended to be used to temporarily stabilize and fixate autogenous bone grafts and/or nonresorbable barrier membranes used for regeneration of bone in the oral cavity.
Titanium healing caps are indicated for use with ITI Dental implants. They are used to allow the site to heal
The modified angled abutment is indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15 degree angled implant as the total degree of angulation is 30 degree or above. The angled abutment is not to be used in conjuction with the Ø3.3 mm Solid Screw Implant for single, posterior restorations.
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retro-molar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cvlinders provide a machined or cast inner surface for mating with the abutment and implant. while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.
The synOcta® angled abutments are indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

ITI self-tapping implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
ITI solid screw implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandibular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The ITI anterior implant is intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the anterior implant is indicated for replacement of single lateral incisors in maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited ( minimum 5 mm) and where vestibulo-oral bone is restricted (minumum 5 mm). The anterior implant can also be used as a support for a full arch implant-borne restoration, but only in conjunction with a standard ITT 4.1mm dental implant.
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The abutment is placed in the dental implant to provide support for a prosthetic restoration such as a crown or bridge. The titanium temporary posts are screwed into the dental implants and serve as a base for a temporary prosthetic restoration. The plastic burn-out copings provide a cast inner surface for mating with the abutment and are for use in casting restorations directly from porcelain-fused-to-metal alloy without the use of machined metal components. The healing cap and closure screw are titanium devices which are mounted onto the soft tissue is sutured in place around the implant and which are intended to protect the inner configuration of the implant. The healing cap also protects the outer 45 degree shoulder of the healing phase and helps stabilize and maintain the soft tissue.
The ITI synOcta angled abutments for Wide Neck Implants are in cases where the placement of an implant requires an angled reconstruction for an optimal result. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
Abutments are intended to be placed in the dental implant to provide support for a prosthetic restorations such as crowns or bridges. The ITI esthetic are indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.
The abutment is placed in a dental implant to provide support for a prosthetic restoration such as a crown or bridge.
ITI® tapered implants are intended for immediate, delayed, or conventional placement in the maxillary and/or mandbular arches to support crowns, bridges, or overdentures in edentulous patients. The ITI Dental Implants are for single-stage or two-stage surgical procedures.
The device that is the subject of this submission is an angled titanium coping, which is a pre-manufactured component offering a pre-formed inner surface for mating with the dental implant abutment. The outer surface of the coping can be adapted to the individual restoration. The coping is angled and is used only with the ITI anterior implant.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The ITI provide synOcta Measo abutments and indicated for cemented restorations in esthetic areas of the mouth. The abutment can be used in single tooth replacements and tooth restorations.
ITI implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. ITI Dental Implants are for single-stage surgery. ITI Dental Implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
The Ortho implant of the Straumann Ortho system is an endosseous implant intended for placement in the mid-sagittal or promedion area of the hard palate or in retromolor positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed ofter orthodontic treatment has been completed.
The Elliptic Matrix is attached onto the Straumann Retentive Anchor abutment to provide support and retention for an overdenture.
The Straumann Temporary Coping is a coping intended to serve as a base for a temporary restoration.
Abutments are intended to be placed into dental bridges to provide support for prosthetic reconstructions such as crowns or bridges.
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Titanium Abutment is indicated for cemented restorations. The abutment can be used in single tooth replacements and multiple tooth restorations.
The Straumann Palatal implant is intended for placement in the mid-sagittal or paramedian area of the hard palate or in retromolar positions. Its purpose is to provide a fixed anchorage point for the attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended after orthodontic treatment has been completed.
Straumann Regular Neck and Narrow Neck implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used. The Straumann Regular Neck Implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations or partially edentulous patients for single-stage or two-stage surgery. The Straumann Narrow Neck implants are intended for surgical placement in the maxilla or mandible to serve as a base for prosthetic reconstructions. Specifically, the Narrow Neck implant is indicated for replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. It is particularly intended for those areas where the interdental space is extremely limited (minimum 5 mm) and where vestibule-oral bone is restricted (minimum 5 mm). The Narrow Neck implant can also be used as a support for a full arch implant-born restoration, but only in conjunction with a standard Straumann 4.1 mm dental implant.
Copings are intended to provide support for prosthetic reconstructions such as crowns or bridges. The Straumann C.A.R.E.S. Ceramic Coping is indicated for cemented restorations. The coping can be used in single tooth replacements and multiple tooth restorations.
The P.004 Implants are intended for immediate, delayed or conventional placement in the maxilla and/or mandbular arches to support crowns bridges or overdentures in edentulous or partially edentulous patients. They are intended for immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns or bridges. Mesa abutments are indicated for cemented restorations particularly in esthetic areas of the mouth. The abutment can be used in single tooth replacements and multiple tooth restorations.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
The Narrow Neck Temporary Coping acts as a basis for the fabrication of individual temporary restorations and small cemented temporary bridges on Straumann Standard Plus Implants 03.3mm Narrow Neck for use up to six months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
P.004 Healing Abutments and Closure Screws are intended for use with the Straumann P.004 Bone Level Implant system to protect the inner configuration of the implant. Healing Abutments have a secondary function to maintain, stabilize and form the soft tissue during the healing process.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for up to 28 days.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns or bridges. The P.004 RC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.
P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months. P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the implant and maintains, stabilizes and forms the healing process for us to six months and should be placed out of occlusion.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns. bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Copings are intended to serve as a base for multi-unit bar or bridge restorations. Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. Protective Caps are intended to protect the outer configuration of the abutment and condition the contours of the soft tissue during the healing phase for up to 6 months. Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The P.004 NC CARES Titanium Abutment is indicated for cemented restoration. The abutment can be used in single tooth replacements and multiple tooth restorations. The P.004 NC CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw retained.
Healing Caps are intended for placement onto dental implants to protect the inner configuration and shoulder of the implant and to maintain, stabilize and form the soft tissue during the healing phase.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following: extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures. The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained. The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained or directly veneered.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann WN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability; small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Modified Dental Implant Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations (via meso structures.)
The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann RC Temporary Abutments are indicated for use in Straumann RC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.
The Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar indicated for use as bars and bridges that attach to dental implants (Straumann RN (Regular Neck) 0 4.8 mm and WN (Wide Neck) 0 6.5 mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Straumann CARES Screw-Retained Bridge can be designed for specific patient sizes and spans that are attached to 2 to 16 implants. The Straumann CARES Dolder Bar can be designed for specific patient sizes and spans that are attached to 2 to 10 implants.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Straumann® dental implants are suitable for the treatment of oral and endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases. Specific indications for small diameter (0 3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.
The Strauman® CARES® Screw-retained Bridge Titanium and Strauman® CARES® Dolder® Bar Titanium are indicated for use as bars and bridges that attach to dental implants (Straumann Regular Neck (RN) 04.8mm and Wide Neck (WN) 06.5mm) in the treatment of partially edentulous jaws for the purpose of restoring chewing function. The Strauman® CARES® Screw-retained Bridge Titanium is available in different sizes and spans and can be fitted on 2 to 16 implants. The Strauman® CARES® Dolder® Bar Titanium is available in different sizes and spans and can be fitted on 2 to 10 implants.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Narrow Neck CrossFit Solid Abutments are indicated for cement-retained single tooth and bridge restorations.
Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetions such as crowns, bridges and overdentures.
The Strauman® CARES® Variobase ™ Abutment is a two-piece dental abutment consisting of the Straumann® Variobase TM Abutment and the Straumann® CARES® Variobase™ Coping which is intended to be placed onto Straumann dental implants to provide support for prosthetic reconstruction such as crowns and bridges. Straumann® CARES® Variobase TM Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. The Strauman® CARES® Variobase ™ Coping polycon® ae in combination with the Straumann® Variobase TM Abutment is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
Straumann® dental implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). When placing implants in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Straumann Temporary Abutments VITA CAD-Temp are indicated for use with Straumann Bone Level and Tissue Level implants for temporary crown and bridge restorations, and to maintain, stabilize and shape the soft tissue during the healing phase for up to six months, and should be placed out of occlusion.
Straumann® dental Implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients (unless specific indications and limitations are present, as stated below). Straumann® dental Implants can also be used for Immediate or early Implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the Implants by the corresponding elements (abutments). When placing in the posterior region, we recommend using only large diameter implants. In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.
Closure Screws, healing caps, and healing abutments, are Intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the Implant and maintain, stabilize and form the healing process. Customizable healing abutments made of PEEK are for use for up to six months.
The Straumann Variobase,. Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase. Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw retained restorations.
The Strauman® Magellan TM abutments are indicated to be placed into Straumann® dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Magellan™ abutments are indicated for screw-retained restorations.
Straumann CARES Screw-Retained Bridges and Bars are indicated for use as bars and bridges that attach to implants and/ or to screw-retained abutments of the Straumann Dental Implant System (SDIS) to provide support for prosthetic reconstructions such as bridges and over-dentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-Retained Bridges and Bars are indicated for screw-retained restorations.
Straumann® dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements).
The Strauman® Screw Retained Abutments are indicated to be placed into the implants of the Strauman® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Screw-Retained Abutments are indicated to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw-Retained Abutments are indicated for screw-retained restorations.
The Straumann CARES® TAN abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/ screw-retained.
Straumann dental implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentuly dentate patients. Straumann dental implants can also be used for immediate or early implantation following extraction or loss of natural teeth, Implants can be placed with immediate function on single-tooth and /or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.
The Straumann® Screw Retained Abutments are indicated to be placed into the NC and RC Bone Level implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The Straumann® Variobase® for CEREC® are titanium alloy abutments placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for CEREC® abutments are indicated for screw-retained single tooth or cementretained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® for CEREC® abutments are to be designed using Sirona inLab software (Version 3.65 or higher) or Sirona CEREC Software (Version 4.2 or higher) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit.
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the corresponding elements (abutments).
Healing abutments, healing caps and closure screws are intended for use with the implants of the Straumann Dental Implant System to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Fixation caps are used to stabilize bone grafts in cases where bone augmentation is being performed in conjunction with implant placement.
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
Straumann® Bone Level Tapered Implants ②2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants ②2.9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments). The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw. Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant connection. Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Straumann® SC Temporary Abutments have a maximum duration of usage of 180 days. Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobas® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center. Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
Straumann Screw retained Abutments are indicated to be placed into the implants of the Straumann Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann Screw Retained Abutments are indicated for screw-retained restorations.
This abutment system is intended to be used in conjunction with ITI endosseous dental implants to provide support for prosthetic devices (crowns, bridges, overdentures) for the functional and oral rehabilitation of edentulous or partially edentulous patients.
The Memfix Screws are intended to be used to temporarily stabilize and fixate autogenous bone grafts and/or nonresorbable barrier membranes used for regeneration of bone in the oral cavity.
Titanium healing caps are indicated for use with ITI Dental implants. They are used to allow the site to heal
The modified angled abutment is indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15 degree angled implant as the total degree of angulation is 30 degree or above. The angled abutment is not to be used in conjuction with the Ø3.3 mm Solid Screw Implant for single, posterior restorations.
Intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The bonding base is indicated for use with a standard ITI implant placed in the posterior oral cavity, to serve as a base for orthodontic attachment during orthodontic treatment.
The Ortho implant of the Straumann Orthosystem is an endosseous implant intended for placement in the median palatal region or in retro-molar positions. Its purpose is to provide a fixed anchorage point for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. It is used temporarily and is intended to be removed after orthodontic treatment has been completed.
Prosthetic accessories are used in conjunction with ITI dental implants in the prosthetic restoration of the implant. These prosthetic accessories include abutments, copings and transfer system components. Abutments are placed into the dental implants to provide support for prosthetic restorations such as crowns, bridges, and overdentures. Prefabricated copings and cvlinders provide a machined or cast inner surface for mating with the abutment and implant. while the outer surface can be adapted to the individual restoration. Transfer system components are used in the process of transferring the situation in the oral cavity to a precise dental model. Protection caps are used to protect the outer configuration of the abutment and to maintain and condition the soft tissues during the prosthetic phase.
The synOcta® angled abutments are indicated for use in cases where the implant requires an angled reconstruction for an aesthetic result. The abutment can be used to restore crowns for single tooth replacements and bridges for bound situations. The angled abutment is not to be used in conjunction with the ITI 15° angled implant as the total degree of angulation is 30 degrees or above.

The provided text is a 510(k) Premarket Notification from the FDA regarding "MRI Compatibility for Existing Straumann Dental Implant Systems." This document primarily lists indications for use for many different Straumann dental implant components and states the device's regulatory classification. It does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or its provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
• Whether a standalone (algorithm-only) performance study was done.
• The type of ground truth used.
• The sample size for the training set.
• How the ground truth for the training set was established.

This document is a regulatory approval letter and accompanying indications for use, not a clinical study report or a technical performance evaluation.

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Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches and for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated for immediate or early implantation following extraction or loss of natural teeth. lmplants can be placed with immediate function on single-tooth and/or multiple-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments).

The Straumann® Dental Implant System is an integrated system of endosseous dental implants with corresponding abutments, healing abutments, closure screws and surgical and prosthetic parts and instruments. The Straumann® Dental Implant System includes various dental implants with different sizes and surfaces (SLActive® and Roxolid®). Straumann® Dental implants are solid screw implants manufactured from titaniumzirconium alloy (Roxolid®) or titanium Grade 4. The implant surface is large-grit sandblasted and acid-etched. In addition, SLActive® is in a chemically activated state, which is preserved by storage in a NaCI solution.

The provided text describes a 510(k) Pre-Market Notification for the Straumann® Dental Implant System. It does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria. Instead, it details a change to the Instructions for Use (IFU) by removing Type II Diabetes and patients previously irradiated in the head and neck from the Cautions/Precautions.

The document discusses performance data but it is a review of published literature to support the change in IFU, not a study performing specific tests against acceptance criteria for the device itself.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance details.
7. Type of ground truth used for a test set.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided document indicates that:

• Bench and animal performance testing was previously submitted in support of referenced predicate devices and deemed representative of the subject devices (Section 5.7). This implies that past studies covered the initial performance metrics, but the details of those studies and their acceptance criteria are not in this document.
• Performance data (for the IFU change): A review and summarization of published literature was conducted regarding dental implant treatment in patients with Diabetes Mellitus (DM) and patients previously irradiated in the head and neck area to justify removing these conditions from "Cautions/Precautions." This involved survival rates and adverse events from existing literature.

While the document references "performance data," it is not structured as an acceptance criteria study report for the device's functional attributes but rather a clinical literature review to justify a labeling change.

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Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.

This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.

However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.

Here's a breakdown of what is applicable from your prompt, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.

The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."

The substantial equivalence is primarily based on:

• Identical Indications for Use.
• Identical fundamental operating principles.
• Identical materials (Ti-6Al-7Nb titanium alloy).
• Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
• Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).

The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.

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The Straumann® PURE Ceramic Implant (Monotype) is indicated for restoration in single tooth gaps and in an edentulous or partially edentulous jaw. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.

The ø3.3 mm reduced diameter implants are recommended for central and lateral incisors only.

The Straumann® PURE Ceramic Implants are made of 100% yttrium-stabilized zirconia. The endosteal region presents macro- and micro-roughness, a ZLA surface. The implant has a 1.8 mm high machined neck. The implant features a monotype design where the ceramic abutment for final restoration is already built in. Straumann® PURE Ceramic Implant prosthetic components are identified with RD (Regular Diameter) corresponding to the neck diameter of 4.8 mm, and ND (Narrow Diameter) corresponding to the neck diameter of 3.5 mm.

In this submission, the device is the Straumann® PURE Ceramic Implants. This documentation discusses a 510(k) premarket notification for a change in the sterilization method of an existing device, rather than the initial introduction of a novel AI/software device. As such, the presented information does not align with the typical structure of an AI/software device study and acceptance criteria as outlined in your request. The core of this submission revolves around demonstrating that a change in sterilization from H₂O₂ plasma to Ethylene Oxide (EO) for a dental implant does not negatively impact its safety and effectiveness.

Therefore, many of the requested categories, such as "Multi-reader multi-case (MRMC) comparative effectiveness study," "Effect size of human readers improvement with AI vs without AI," "Stand-alone algorithm performance," "Training set sample size," and "Ground truth for the training set," are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to address the change in sterilization method.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly linked to maintaining the same performance and safety profile as the predicate device despite the change in sterilization method. The "reported device performance" refers to the results of the tests conducted to confirm this.

2. Sample Size Used for the Test Set and the Data Provenance:

• The document does not specify exact sample sizes for each test (e.g., how many implants were tested for mechanical strength, how many packages for transportation studies, etc.). It refers to "subject devices" and "worst-case environmental and handling changes."
• Data Provenance: The studies were conducted by the manufacturer (Straumann USA, LLC on behalf of Institut Straumann AG), and the data are part of a regulatory submission to the FDA for a device to be marketed in the US. The provenance is therefore related to the manufacturer's internal testing. It is retrospective in the sense that the studies were performed prior to the submission; they are not drawn from real-world patient data (prospective or retrospective) in the context of device performance in humans.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• This concept is not directly applicable here. The "ground truth" for these tests is defined by established international standards (ISO 11135, ISTA 2A, ASTM F1980, ISO 10993-1, ISO 14801) and FDA guidance documents. The "experts" are the engineers, scientists, and technicians who designed and executed these tests and interpreted the results according to these predefined standards. Their qualifications would align with expertise in sterilization validation, biocompatibility, mechanical engineering, and quality assurance for medical devices. Specific numbers and qualifications of individual experts are not provided in this type of summary.

4. Adjudication Method for the Test Set:

• Not applicable in the context of expert review of images or data. Adjudication in this context relates to how the test results are evaluated against the relevant standards and how compliance is determined. This is typically done through interpretation by the conducting laboratory/personnel and reviewed by regulatory affairs, quality assurance, and potentially notified bodies or the FDA, based on the pass/fail criteria outlined in the standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This submission is not about an AI/software device or its impact on human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" is based on established international standards and regulatory guidance documents for medical device performance and safety. For example:
  • Sterility: ISO 11135 (Sterility Assurance Level of 10⁻⁶)
  • Biocompatibility: ISO 10993-1 (Pass/fail criteria for cytotoxicity, residue levels)
  • Mechanical Strength: ISO 14801 (defined load limits and fatigue cycles)
  • Packaging: ISTA 2A, ASTM F1980 (criteria for package integrity and shelf life)
• The ground truth is not derived from expert consensus on clinical cases, pathology, or outcomes data in the usual sense of an AI study. Instead, it's about meeting pre-defined scientific and engineering benchmarks.

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set exists for this type of device submission.

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Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding components (abutments).

The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.

Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.

Straumann® SC Temporary Abutments are indicated for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.

The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.

The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.

There are three components to the Straumann® SC Variobase™ Abutments:

• Straumann® SC Variobase™ Abutments (Ti-base)
• Prosthetic restoration (coping and/or crown)
• Basal Screw

The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

• Cast materials:
  • Type 4 metals (ISO 22674)
  • Base metal alloys (e.g., cobalt-chromium (CoCr))
  • Noble metal alloys (e.g., gold alloy)
• Press materials:
  • IPS e.max® Press Ceramic (K120053)
• Digital materials:
  • coron®
  • zerion® LT
  • polycon® ae

All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.

The provided document (K162890) describes the regulatory submission for Straumann dental implants and associated components. However, it does not contain information about studies proving the device meets acceptance criteria for performance metrics related to diagnostic accuracy, such as sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic or AI-powered devices.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through various non-clinical tests. The "acceptance criteria" here relate to the successful completion of these engineering and safety tests, rather than clinical performance metrics for diagnostic capability.

Therefore, the requested information cannot be fully provided in the format desired for diagnostic devices because this submission deals with dental implants, not a diagnostic AI.

However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.

Acceptance Criteria and Device Performance (Not applicable in the typical sense for diagnostic AI):

The document does not present acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) because the devices (dental implants and abutments) are not diagnostic AI devices. Instead, the "performance testing" focuses on engineering, biocompatibility, and sterilization validations to demonstrate substantial equivalence to predicate devices.

Summary of Performance Testing Conducted (which can be seen as meeting "acceptance criteria" for safety and efficacy in this context):

1. Sterilization Validation (Section 5.8.1):

   • Acceptance Criteria: Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
   • Reported Device Performance: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated.

2. Biocompatibility Testing (Section 5.8.2):

   • Acceptance Criteria: Compliance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016". The subject devices should have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, raising no new biocompatibility issues.
   • Reported Device Performance: The subject devices have identical biocompatibility characteristics to the primary and reference predicate devices. Therefore, no additional biocompatibility testing was required or performed.

3. Software Verification and Validation Testing (Section 5.8.3): (Applicable to CARES Visual software for abutment design, which is part of the manufacturing process, not a diagnostic AI)

   • Acceptance Criteria: Compliance with FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".
   • Reported Device Performance: Software verification and validation testing were conducted; the software for the device (CARES Visual) was considered a "moderate" level of concern.

4. Bench Testing (Section 5.8.4):

   • Acceptance Criteria: Compliance with the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue, static strength, and insertion torque tests.
   • Reported Device Performance: Dynamic fatigue, static strength, and insertion torque tests demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.

Regarding the specific questions about diagnostic AI studies:

1. A table of acceptance criteria and the reported device performance: As explained above, not applicable for diagnostic metrics. The performance relates to engineering and safety tests.
2. Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical engineering and bench tests, not studies on patient data for diagnostic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set or ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a diagnostic AI scenario. The "ground truth" for the bench tests would be the established engineering standards and physical properties of the materials.
8. The sample size for the training set: Not applicable, as there is no AI training set.
9. How the ground truth for the training set was established: Not applicable.

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