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510(k) Data Aggregation
(265 days)
Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices.
Straumann® BLX Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Straumann® TLX Dental Implants, SLActive®
Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive®
Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function.
Specific indications for use
Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm
The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Roxolid® Standard Plus 4 mm Short Implants
Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone 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.
Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for:
Fixed denture prosthesis/splinted units (one implant per unit).
Pontic cases in combination with at least one longer implant.
Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants.
Titanium Ø 3.3 mm implants
ø3.3 mm S and SP RN implants are to be used only for the following indications:
Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure.
The SLActive® Implants from the Straumann® Dental Implants System includes:
SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm
SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm
SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm
SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm
SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm
SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm
SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm
SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm
SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants
The device being discussed is "Straumann® SLActive® labeling changes" (K223083). This 510(k) pertains to labeling changes for existing Straumann® SLActive® dental implants and does not introduce new implants or modify existing implant designs. The primary predicate device is K171784 – Straumann Dental Implant System, with several other Straumann® implant systems listed as reference devices.
The acceptance criteria and supporting study are primarily focused on substantiating the updated labeling, particularly regarding the use of SLActive implants in smokers and general wording clarifications.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Evaluation by FDA) | Reported Device Performance (Summary from Submission) |
|---|---|
| For General Labeling Changes (Changes to Indications for Use wording): | |
| Demonstrated substantial equivalence to predicate devices, ensuring that differences in wording do not alter the application, safety, or effectiveness of the devices. | The provided comparative tables for Indications for Use (Table 2) show that the proposed wording is Equivalent to the primary and reference predicate devices. |
- All indications continue to allow for implant placement in the jaw, providing support for single-tooth or multiple-tooth restorations, and allowing for immediate loading when good primary stability is achieved.
- Information regarding prosthetic restorations was not excluded but relocated to the device description for better understanding.
- The requirement for "4 or more implants for fully edentulous patients" was removed from indications for use as it is considered "common knowledge."
- New specific Indications for Use for Ø 3.3 mm implants provide more details.
- The "Precaution" section of the Instructions for Use now addresses the use of narrow implants in the molar region.
- For specific implant types (e.g., BLX implants), the single-tooth restoration was considered the "worst case due to the higher masticatory load," indicating an understanding of potential stress. |
| For "Smokers' Claim" (Outcomes of SLActive implants in smokers are encouraging):
Supported by clinical evidence demonstrating that implant performance (e.g., failure rates, adverse events) is not significantly worse in smokers compared to non-smokers with SLActive implants.
Demonstrated through systematic literature review or clinical studies. | A systematic literature search identified 5 publications. - 251 SLActive implants were placed in 237 patients (age range 25-65 years old).
- Studies included titanium or titanium-zirconium alloy implants with SLActive surfaces, diameters 3.3-4.8 mm, and lengths 8-12 mm.
- Reported adverse events (failure to osseointegrate, peri-implantitis, spinning/mobility during surgery, late failure, bone loss, abutment loosening, paresthesia, acrylic/porcelain chipping) were not reported at a higher rate in smokers compared to non-smokers.
- Implant failure rates were not found to be significantly different in smoking compared to non-smoking patients with SLActive implants.
- References: Alsahhaf A (2019), Xiao W (2021), Chen Y (2017), Sener T (2010), Luongo G (2016). (Note: Sener and Luongo were cited in the text but not fully listed in the provided references section). |
| Sterility:
Sterilization process validated to SAL of 10^-6.
Meets pyrogen limit specifications. | - Sterilization via gamma irradiation after final packaging. - Validated to a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 11137-1 and ISO 11137-2 (VDmax25 method).
- Pyrogen limit specifications met with LAL Endotoxin Analysis, testing limit of 20 EU/device (per FDA Guidance and ISO 10993-1). |
| Biocompatibility:
Biological assessment performed according to ISO 10993-1 and FDA Guidance. | - Biological assessment performed according to ISO 10993-1 and FDA Guidance "Use of International Standard ISO 10993-1..." for each device. (Results are not detailed but the assessment was stated to be performed). |
| Dynamic Fatigue:
Assessment conducted per FDA guidance and ISO 14801. | - Dynamic fatigue assessment conducted according to FDA guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. - Test covers permanent restoration of implants without failure. (Results are not detailed but the assessment was stated to be performed). |
| Insertion Performance:
Demonstrated adequate insertion torque in different bone classes. | - Insertion tests performed for the subject implants. - Showed adequate insertion torque in different bone classes when inserted according to the surgical procedure. (Results are not detailed but the assessment was stated to be performed). |
| MR Safety:
Evaluated for MR Conditional status. | - Obtained MR Conditional status per K180540. - MR Conditional tests conducted according to FDA's Guidance "Testing and Labeling Medical Devices for Safety in Magnetic Resonance (MR) Environment." (Results are not detailed but the status was noted). |
2. Sample Size Used for the Test Set and Data Provenance
The core of the "study" for the labeling changes, especially concerning the "smokers' claim," was a systematic literature review, not a direct clinical trial conducted by the applicant for this 510(k).
- Sample Size for Smokers' Claim: The literature review included data from 5 publications which collectively involved 251 SLActive implants placed in 237 patients.
- Data Provenance: The data came from published clinical studies. The document does not specify the exact country of origin for all studies, but at least two cited papers involve authors from China (Xiao, Chen), one from Saudi Arabia (Alsahhaf), and the ITT World Symposium (Chen 2017) was held in Switzerland. The studies are explicitly described as "clinical studies," implying they were prospective or retrospective clinical investigations.
For other non-clinical performance characteristics (sterility, biocompatibility, dynamic fatigue, insertion tests, MR safety), these appear to be internal bench tests and assessments conducted by the manufacturer, or previously established for the cleared predicate/reference devices. No specific sample sizes for these tests are provided in this summary, but it's stated that "No significant changes have been performed to the subject implants since clearance so previously cleared bench data continue to be representative."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- For the "smokers' claim" (literature review): The "ground truth" (i.e., the reported outcomes like adverse event rates and implant failure rates) was established by the authors of the original 5 clinical publications. The document does not specify the qualifications of these individual authors. However, given they are "published clinical studies," it's understood that dental/medical professionals (e.g., oral surgeons, periodontists, implantologists) would have conducted these studies and reported the outcomes.
- For the equivalence discussion of Indications for Use: The "ground truth" is established by comparing the proposed wording against the previously cleared wording in the primary and reference predicate devices, which were approved by the FDA based on clinical and scientific evidence at the time of their clearance. This comparison itself is performed by regulatory affairs experts on behalf of the manufacturer.
4. Adjudication Method for the Test Set
- For the "smokers' claim" (literature review): The adjudication of adverse events and implant failure rates was performed within each of the original 5 clinical studies. The specific adjudication methods used in those individual studies are not detailed in this 510(k) summary. Given the nature of scientific literature, these studies would typically involve clinical follow-up and assessment by the treating clinicians/researchers.
- For the Indications for Use equivalence: This is a comparison process, not a clinical adjudication. The equivalence of wording is assessed by regulatory experts against the historical FDA clearances.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was NOT done. This submission is for labeling changes for dental implants, not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- Not applicable. This submission is for a medical device (dental implants), not a software algorithm or AI.
7. The Type of Ground Truth Used
- For the "smokers' claim": The ground truth was clinical outcomes data reported in peer-reviewed published clinical studies. These outcomes included adverse events (e.g., failure to osseointegrate, peri-implantitis, bone loss) and implant failure rates.
- For other performance tests (sterility, fatigue, etc.): The ground truth would be established through defined bench testing protocols and adherence to international standards (e.g., ISO, FDA guidance).
8. The Sample Size for the Training Set
- Not applicable. This submission is not for a machine learning or AI device that requires a training set. The "smokers' claim" was based on a literature review which leverages existing published clinical data, akin to an external validation set rather than a training set for the current submission.
9. How the Ground Truth for the Training Set was Established
- Not applicable. (See point 8.)
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(331 days)
Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.
Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The dental implants are provided in body diameters of 4 mm and 5 mm, and each diameter is provided in 8, 10, and 12 mm lengths. The dental implants are manufactured from Y - TZP zirconia conforming to ISO 13356. The system also includes a healing cap, gingiva formers, and a temporary abutment manufactured from polyetheretherketone (PEEK). Zircoma abutments for single-unit and multi-unit cemented restorations are provided in straight and 15° angled designs. For retention of overdentures, Zirconia Locator-type abutments are provided in straight and 15° angled designs. Occlusal (abutment) screws are provided in Ti-6Al-4V alloy conforming to ASTM F136 and in zirconia.
The subject device implants and Healing Cap are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).
The provided text is a 510(k) summary for the Z5-BL dental implant. It focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics, and performance data. However, it does not contain information about acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance metrics (e.g., accuracy, sensitivity, specificity, or MRMC studies).
The document explicitly states: "No clinical data were included in this submission." This means there is no performance data related to human-in-the-loop studies, standalone AI performance, or any studies that would involve establishing ground truth from expert consensus or pathology for evaluating AI model performance.
Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria from the provided text, as it describes a traditional medical device submission for dental implants, not an AI/ML-driven device.
To answer your specific questions in the context of an AI/ML device, I would need a different type of document that describes performance data related to an AI/ML algorithm.
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(186 days)
ArgenIS Titanium Abutments are intended to be single use available by prescription only in the construction of dental restorations supported by the endosseous dental implant. The ArgenIs Titanium Abutments are designed to specifically fit an individual patient's needs of the final restoration. All digitally designed abutments files are intended to be sent to Argen manufacturer for milling. The ArgenIS Titanium Abutments are compatible with the following implant systems:
| IMPLANT BRAND
NAME | PLATFORM | Manufacturer | Implant Trade
Name | Implant
Line/Connection | Implant
Diameter |
|---------------------------------|-----------|--------------------------|---------------------------------------------------|--------------------------------------------------------------|------------------------------|
| Nobel Biocare Replace
Select | 6.0mm | Nobel Biocare USA | Nobel Replace
Tapered
Conical
Connection | Nobel Replace
Internal Conical
Connection WP | 6.0mm |
| Nobel Biocare Active | 3.5mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Nobel Biocare Active | 4.3/5.0mm | Nobel Biocare AB | NobelActive
Internal
Connection
Implant | Nobel Active
Internal Conn.
RP and NP | 3.0, 3.5, 4.3,
5.0mm |
| Straumann Bone Level | 3.3mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
NC | 3.3mm |
| Straumann Bone Level | 4.1/4.8mm | Straumann USA | Straumann
Bone Level
Tapered
Implants | Bone Level
Internal Conn.
RC | 4.1, 4.8mm |
| Straumann Synocta | 4.8mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
4.8mm RN (Reg.
Neck) | 4.8, 6.5mm |
| Straumann Synocta | 6.5mm | Institut Straumann
AG | Straumann
Dental Implant | Synocta Implant
Internal Conn.
6.5mm (Wide
Neck) | 4.8, 6.5mm |
| Astra Tech OsseoSpeed | 3.5/4.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed | OsseoSpeed
Internal Conical
Connection RP | 3.6, 4.2, 4.8mm |
| Astra Tech OsseoSpeed | 4.5/5.0mm | Astra Tech AB | AstraTech
Implant
OsseoSpeed
Plus | OsseoSpeed Plus
Internal Conical
Connection RP | 3.0, 3.5, 4.0, 4.5,
5.0mm |
Argen IS Titanium Abutments are designed specifically for an Individual patient and then milled from a Titanium blank with a pre-milled interface correlating to a specific implant system. This abutment can be fixed in the laboratory model work containing the implant analog for final construction of the related prosthetic restoration. The Argen IS Titanium Abutments are then intended to be fixed in the mouth with the included prosthetic screw. The Argen IS Titanium Abutments are supplied with 2 screws (1) A Final Screw for fixing to the endosseuos Implant. (2) A lab screw for Laboratory use during construction of related restoration to avoid any damage to the final prosthetic screw will be marked "final Screw". The final screw must be torqued on the endosseuos Implant with the specific torque setting provided. The device is finalized at the Argen facility and provided to the dental laboratory in a final patient specific form.
Minimum and Maximum Gingival Height is 0-6mm
Minimum diameter at abutment/implant interface is 3.5mm to interface base
Maximum length of abutment from abutment/implant interface is 12.5mm
Minimum length of abutment post (length above the abutment collar/gingival height) is 4.0mm.
Minimum wall thickness at abutment/implant interface is 0.65mm
Maximal angle in relationship to the long axis of implant is 30°
The available range of diameters and connection type is summarized on the table below:
This document describes a 510(k) premarket notification for the "ArgenIS Titanium Abutments" by Argen Corporation. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a clinical study or performance goals with clinical outcomes. Therefore, much of the requested information (like expert ground truth, adjudication methods, MRMC studies, training set details, or effect size of human readers with AI assistance) is not applicable to this type of device and submission.
Here's an analysis of the provided text in relation to your request, highlighting what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study with numerical targets and achieved results. Instead, it demonstrates substantial equivalence by comparing the device's technical characteristics and performance to predicate devices. The "performance" in this context refers to bench testing to ensure functional compatibility and mechanical integrity, not clinical outcomes.
| Feature | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Material | Predicate devices use Titanium-6AL-4 Vanadium ELI Alloy or CP Titanium. | ArgenIS Titanium Abutments use Titanium-6AL-4 Vanadium ELI Alloy. (Consistent with predicate K143051 and functionally equivalent to CP Titanium for this application). |
| Intended Use | Similar to predicate devices: construction of dental restorations supported by endosseous dental implants, single use, prescription only, designed to fit individual patient needs. | ArgenIS Titanium Abutments share the same intended use: single-use, prescription-only for dental restorations supported by endosseous dental implants, designed for individual patient needs. "Minor changes in descriptive terms used in the indications for use do not change the intended use of the proposed device." |
| Prosthetic Connection | Compatibility with specific implant systems (Nobel Biocare, Straumann, Astra Tech) as listed for predicate devices and the new device. | ArgenIS Titanium Abutments are compatible with a range of Nobel Biocare, Straumann, and Astra Tech implant systems, similar to the scope covered by the various predicate devices. |
| Implant Diameters/Lengths | Within the range of existing predicate devices. | ArgenIS supports diameters 3.3mm, 3.5mm, 4.0mm, 4.1mm, 4.3mm, 4.5mm, 4.8mm, 6.0mm, 6.5mm, which are covered by the collective range of the predicate devices. |
| Type of Retention | Screw-retained to the implant; prosthesis cement-retained to the abutment, consistent with predicate devices. | ArgenIS Titanium Abutments are screw-retained to the implant, with the prosthesis cement-retained to the abutment. (Identical to all predicates shown). |
| Manufacturing Process | Machining, consistent with predicate devices. | ArgenIS Titanium Abutments are manufactured via machining. (Identical to all predicates shown). |
| Abutment Sterilization | Moist Heat (Steam), consistent with predicate devices. | ArgenIS Titanium Abutments use Moist Heat (Steam) for sterilization. (Identical to all predicates shown). |
| Abutment Angulation | Within the range of predicate devices (0°-30°). | ArgenIS Titanium Abutments have an angulation range of 0° - 30°. (Consistent with primary predicate K143051, and overlaps with/encompasses other predicates' ranges). |
| Dimensional Compatibility | Demonstrated through tolerance analysis and functional fit checks. | "Testing included tolerance analysis to ensure abutment/implant interface compatibility. Functional fit checks of abutment blank to compatible implant and prosthetic screw. Testing showed correct functionality of the device as per its intended use, including dimensional compatibility, and mechanical performance." |
| Mechanical Performance (Fatigue) | Conformance to ISO 14801 for worst-case scenarios (smallest diameter, shortest length from each platform). This implicitly means meeting at least the performance levels of predicate devices that would also conform to ISO 14801. | "Fatigue testing was conducted on worst case scenario samples. Worst case scenario was defined as the smallest diameter and shortest length from each platform. The worst case scenarios from each of the proposed platforms were tested per ISO 14801." (The document asserts conformance to performance specifications, implying successful completion of these tests in line with relevant standards and predicate performance). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "worst case scenario samples" for fatigue testing but does not specify the exact number of samples. This is typical for bench testing where the focus is often on specific critical configurations rather than a large statistical sample of all possible configurations.
- Data Provenance: This was "Non-clinical test data" from "Bench testing." As such, there is no country of origin for patients or retrospective/prospective classification. It's laboratory data.
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)
Not applicable. This device is an implant abutment, and the testing involved engineering/mechanical validation (bench testing), not clinical diagnosis or interpretation requiring expert human judgment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no human expert adjudication of test results in the clinical sense. Performance was determined by objective measurements during bench testing against engineering specifications and 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 device is a dental implant abutment, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering specifications, material properties, and relevant international standards (e.g., ISO 14801). For compatibility and fit, it's about precise dimensional measurements and physical mating tests against the actual or specified dimensions of compatible implant systems.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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(108 days)
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 (abutments).
The subject devices represent a line extension of the previously cleared implants of the Straumann Dental Implant System. The subject devices represent a full line of Straumann implants having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and acid etch surface finish in the same diameters, lengths, emergence profiles and implant-to abutment interfaces as previously cleared implants in the Straumann Dental Implant System.
This document (K150938) describes the Straumann® Dental Implant System - Roxolid® SLA Implants, which are dental endosseous implants. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The key change is the use of a Titanium-13Zirconium alloy (Roxolid®) for the implants, compared to commercially pure Grade 4 Titanium in the predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" for specific performance metrics in a tabular format. Instead, it relies on demonstrating that the new material change (Roxolid®) does not negatively impact the performance compared to the predicate devices which used commercially pure Grade 4 Titanium. The performance is assessed through various bench studies.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: The Ti-13Zr alloy (Roxolid®) must be shown to be equivalent or superior to commercially pure Grade 4 Titanium for dental implant applications. | The subject devices are made from Ti-13Zr alloy (Roxolid®), which has been previously reviewed and cleared in K111357, K081419, K083550, K121131, and K122855. This implies its biocompatibility and suitability are accepted. Technological characteristics (connections, diameters, lengths, surface finish) are identical to predicate devices. |
| Dynamic Fatigue Performance: The new material implant system must meet established dynamic fatigue standards for endosseous dental implants. | Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission. (Specific acceptance values are not provided in this summary, but the stated consistency with ISO 14801 implies meeting its criteria). |
| Transfer Piece Removal Force: The force required to remove the transfer piece must be within acceptable limits. | Transfer Piece removal force data has been provided. (Specific data and acceptance limits are not provided in this summary, but the provision of data implies it met acceptable levels). |
| Surface Finish Characteristics: The SLA surface finish must be consistent with prior cleared devices. | Surface finish characteristics and surface chemistry analysis data have also been provided. The documents state the SLA surface finish remains the same as the predicate devices. |
| Sterilization Efficacy: The sterilization method must achieve the required sterility assurance level. | Gamma Irradiation, 25 kGy min., validated per ISO 11137-1 and ISO 11137-2 to an SAL of $1 \times 10^{-6}$. This is identical to the predicate device. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that the substantial equivalence of the device is addressed via "bench studies" and "dynamic fatigue test data consistent with FDA guidance and ISO 14801." However, it does not provide specific sample sizes (e.g., number of implants tested), the exact test parameters beyond "ISO 14801," or the provenance of the data (country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, which are not included in this summary.
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)
This is a medical device approval based on bench testing and material equivalence, not on clinical performance or interpretation of images by experts. Therefore, the concept of "experts used to establish the ground truth" for a test set (like in a diagnostic AI study) is not applicable here. The "ground truth" for the bench tests would be the results obtained following the specified standards (e.g., force values, cycles to failure).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this submission relies on bench testing and material characterization, not human interpretation or adjudication of outputs.
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-assisted diagnostic tool. It is a dental implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on engineering standards and scientific verification of material properties and mechanical performance. This includes:
- Material composition analysis: Verifying the Ti-13Zr alloy (Roxolid®) composition.
- Mechanical testing: Dynamic fatigue testing according to ISO 14801.
- Surface characterization: Analysis of the SLA grit blast and acid etch surface finish characteristics and surface chemistry.
- Sterilization validation: Conformance to ISO 11137-1 and ISO 11137-2 for sterility assurance level (SAL).
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this traditional medical device approval process. The device's performance is not learned through data like an AI model; it's designed and verified through engineering principles and testing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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(150 days)
The CreoDent Solidex® Customized Abutment is intended for use with an endosseous implant to support a prosthetic device in patients who are partially or completely endentulous. The device can be used for sinqle or multiple-unit restorations. The prosthesis can be cemented or screw retained to the abutment. An abutment screw is used to secure the abutment to the endosseous implant.
The CreoDent Solidex® Customized Abutment is compatible with the following:
- . Biomet 3i Osseotite Certain Dental Implants 3.25mm, 4.0mm, 5.0mm, 6.0mm
- o Straumann Bone Level Implants 3.3mm. 4.1mm. 4.8mm
The Solidex® Customized Abutment is Ti-6A1-4V Eli titanium alloy meets ASTM F-136 Standard and Screw is CP TI Gr4 meets ASTM F67 and is designed to be screw retained for use with endosseous dental implants to provide support for a prosthetic restoration. These abutments are indicated for cement or screw retained restorations. Solidex® Customized Abutments are compatibe with:
- Biomet 3i Osseotite Certain 3.25mm, 4.0mm, 6.0mm diameter implants K063341 .
- Straumann Bone Level implants 3.3mm, 4.1mm, 4.8mm K083550 K121131 .
The design of subject device is customized to the requirements of each patient as may be specified by the prescribing dentist. Customization is limited by the minimum dimensions for wall thickness, diameter, height, collar height and angulation.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CreoDent Solidex® Customized Abutment:
Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a traditional clinical trial report with specific acceptance criteria as might be found for a novel device. The "acceptance criteria" here are implicitly related to demonstrating performance equivalence to the predicate devices through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of this 510(k) summary, the "acceptance criteria" are the demonstration of equivalent or superior performance to the predicate devices through specific non-clinical tests. The reported device performance is that these tests showed sufficient strength and compatibility.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength (Fatigue Testing): Device maintains structural integrity and function under dynamic loading conditions, comparable to or better than predicate devices. | "Static/Fatigue testing was conducted in accordance with ISO 14801:2007E Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario..." demonstrated "sufficient mechanical strength for their intended clinical application." |
| Dimensional Compatibility: Device fits correctly and securely with specified implant systems. | "Reverse engineering dimensional analysis using compatible implant fixtures..." confirmed compatibility. |
| Sterilization Efficacy: Sterilization process is effective in rendering the device sterile. | "Sterilization validation according to ISO 17665-1 was performed." |
| Material Equivalence/Superiority: Material properties are suitable for the intended use and are equivalent or superior to predicate devices. | Abutment is Ti-6A1-4V Eli titanium alloy (ASTM F-136 Standard), which is a "higher grade material with more tensile strength" than the primary predicate's CP Ti Gr4 (ASTM F67). Screw is CP Ti Gr4 (ASTM F67), same as predicate. Differences were mitigated by fatigue testing. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical laboratory testing, not human or animal clinical trials. Therefore, the concept of a "test set" in the context of clinical data or AI systems does not directly apply.
- Sample Size for Testing: The document does not specify the exact number of abutments or implants tested in the static/fatigue testing, dimensional analysis, or sterilization validation. It refers to these as "testing" or "analysis" without numerical details on the quantity of items used.
- Data Provenance: The data comes from non-clinical laboratory testing conducted by the manufacturer, CreoDent Prosthetics, Ltd. There is no information regarding country of origin of data beyond the manufacturer's location in New York, USA, or whether it's retrospective or prospective, as it's not a clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for this device's performance is established through internationally recognized engineering standards (ISO 14801:2007E, ISO 17665-1) and direct physical/mechanical testing, not through expert clinical consensus or interpretation of images/data by human experts.
4. Adjudication Method for the Test Set
This section is not applicable. As the testing is non-clinical and based on objective engineering measurements and standards, there is no need for an adjudication method involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI algorithms that rely on human interpretation of outputs. The CreoDent Solidex® Customized Abutment is a physical medical device (dental implant abutment), not a diagnostic or AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is a physical product, not an algorithm or AI software.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating the safety and effectiveness of the CreoDent Solidex® Customized Abutment is based on:
- Engineering Standards and Specifications: Adherence to ISO standards (ISO 14801:2007E for fatigue, ISO 17665-1 for sterilization) and ASTM material standards (ASTM F-136, ASTM F67).
- Objective Mechanical and Physical Measurements: Results from static/fatigue testing and reverse engineering dimensional analysis.
- Comparison to Predicate Devices: Demonstrating that the subject device's performance, materials, and indications for use are substantially equivalent to legally marketed predicate devices.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable for the same reason as above; there is no training set for a physical medical device.
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(319 days)
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
The SATURN Dental Implant employs a new strategy that of extended sub-crestal threads, expanded out in a wing-like effect to engage socket walls mid-crestally. The implants material composition is: TI 6AL 4V - ELI
The system consists of a variety of bone screw implants in three diameters ø 3.8, 4.2, 5.0 mm diameter. Each respective diameter is available in various lengths from 8 mm to 16mm. The bone screw (implant) is connected to the abutment via an internal connecting screw while the alignment of the abutment is determined.
SATURN Dental Implants are tapered internal hex implants, designed to enable easy insertion, while supporting initial stability. The variable thread (coil) design enables self-tapping, thus providing solution for a variety of bone conditions.The internal hexagon helps to minimize rotation. SATURN Dental Implant System offers a solution for immediate placement and immediate loading.
The SATURN Dental Implant System is cleared for marketing in Europe. The device was implanted in thousands of patients in Israel and Europe.
Materials:
The components are manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136.
Function:
The SATURN Dental Implant System is intended for surgical placement in the maxillary and/or the mandibular arch, to support crowns, bridges, or over dentures, in edentulous or partially edentulous patients. It is intended to provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function.
The System is intended to be used in either single tooth or multiple teeth restoration for immediate loading after extraction when good primary stability is achieved and with appropriate occlusal loading.
The procedure can be accomplished in a one-stage or two-stage surgical operation.
The medical device in question is the SATURN Dental Implant System by Cortex Dental Implants Industries Ltd.
Here's an analysis of the acceptance criteria and the supporting study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are implied by the performance of the predicate devices and the outcome of the non-clinical and clinical tests demonstrating this equivalence.
| Aspect | Acceptance Criteria (Implied by Predicate Equivalence & Regulatory Standards) | Reported Device Performance (SATURN Dental Implant System) |
|---|---|---|
| Material Composition | Biocompatible, suitable for dental implant use (e.g., Titanium alloy). | Manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. This is consistent with predicate devices (Nobel Active: Titanium; Straumann Bone Level Implant: Titanium alloy). |
| Implant Diameters | Comparable range to legally marketed predicate devices. | Available in ø 3.8, 4.2, 5.0 mm. This range is comparable to Nobel Active (3.5-4.3 mm) and Straumann (4.1-4.8 mm). |
| Implant Lengths | Comparable range to legally marketed predicate devices. | Available in 8 mm to 16 mm. This range encompasses and extends beyond Nobel Active (10-15 mm) and Straumann (8-14 mm). |
| Implant Form | Root form. | Root form. Consistent with predicate devices. |
| Insertion Mechanism | Self-tapping capability. | Variable thread (coil) design enables self-tapping, providing solutions for various bone conditions. Consistent with predicate devices. |
| Mechanical Safety/Fatigue | Must meet ISO 14801:2007 Dentistry-Implants- Dynamic fatigue test for Endosseous Dental implants, and FDA guidelines for "worst-case scenario" (e.g., longest implant with highest angled abutment). | Passed Static and dynamic compression performance test per ISO 14801:2007. The worst-case scenario (16mm implant with 30° angled abutment) was tested. The results "indicate that the SATURN Dental Implant System is equivalent to the predicate devices cited in this submission." (Specific numerical results are not provided in this summary). |
| Clinical Performance | Support for crowns, bridges, or overdentures; restoration of chewing function; ability for immediate loading with good primary stability; minimal bone loss. | "Long-term results of several patients implanted with the SATURN Dental Implant System were presented and support the biomechanical theory concerning the loading on the implant. The implant wing reduces the pressure on the implant neck resulting in less absorption in the neck. The cases presented in this report show no bone loss in the neck of the implanted SATURN." |
| Intended Use | Must be substantially equivalent to predicate devices. | Intent to support crowns, bridges, or overdentures in edentulous or partially edentulous patients, restore chewing function, for single or multiple teeth restoration, and immediate loading when primary stability is achieved. This is affirmed to be substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Non-Clinical Test (Fatigue): Not explicitly stated as a number of devices. The test was conducted on the "longest implant (16mm) in combination with the highest angled abutment (30°)." It implies testing of a sufficient number of samples of this specific configuration to meet ISO 14801 standards, but the exact count isn't given.
- Sample Size for Clinical Test (Case Reports): "Long-term results of several patients implanted with the SATURN Dental Implant System were presented." The exact number of patients is not provided.
- Data Provenance: The document states, "The device was implanted in thousands of patients in Israel and Europe." This implies the clinical experience referenced is retrospective from real-world usage in Israel and Europe.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Non-Clinical Test: Ground truth is established by adherence to the ISO 14801:2007 standard and FDA guidelines for fatigue testing. No human experts are described as establishing ground truth in this context; rather, the standard dictates the methodology and acceptance criteria.
- Clinical Test (Case Reports): The summary refers to "Case Reports" and mentions the "biomechanical theory." While undoubtedly clinical experts (dentists/oral surgeons) were involved in collecting and reporting these cases, the document does not specify the number or qualifications of experts involved in establishing a formalized "ground truth" for the purpose of a study. The presentation of results seems to be based on the observed clinical outcomes in these patients.
4. Adjudication Method for the Test Set
- Non-Clinical Test: No adjudication method described; results are determined by whether the tested implants meet the criteria of ISO 14801.
- Clinical Test (Case Reports): No formal adjudication method is mentioned for the clinical case reports. The cases were "presented," suggesting a review of clinical outcomes, but not a blinded consensus or similar adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The submission relies on non-clinical testing and clinical case reports to demonstrate substantial equivalence, not a direct comparison of human readers with and without AI assistance. This device is an implant, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The SATURN Dental Implant System is a physical dental implant, not an algorithm or AI system. Therefore, no standalone (algorithm only) performance study was conducted.
7. Type of Ground Truth Used
- Non-Clinical Test: The ground truth for mechanical performance is defined by the ISO 14801:2007 standard for dynamic fatigue testing.
- Clinical Test (Case Reports): The ground truth for clinical performance is effectively the observed clinical outcomes in the reported patient cases, specifically "no bone loss in the neck of the implanted SATURN." This is a form of outcomes data and expert observation, but not a formally established "ground truth" in the way it might be for a diagnostic device.
8. Sample Size for the Training Set
Not applicable. This device is a physical dental implant, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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