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BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. Bio Plant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.

The Bio Plant System includes a variety of types and sizes of precision-machined self-tapping root-form implants, abutments and accessory fixtures manufactured from biocompatible, commercially pure (CP) titanium or biocompatible, wrought titanium or gold alloy. The implants are available with hex-lock features and either smooth (bright) or textured (abrasive blasted) surface finish. Implants range in diameter from 3.3 mm to 6.0 mm and in length from 7 mm to 18 mm. The implants are intended to be surgically inserted into the upper and/or lower jawbone and serve as a substitute or replacement tooth while providing a stable and secure foundation for restorations. Drill sequences, arms and insertion instruments, as specified, are available.

The provided text describes the Cowell Medi BioPlant System, an endosseous dental implant system, and its acceptance criteria as defined for its 510(k) submission to the FDA. The submission relies heavily on demonstrating substantial equivalence to predicate devices and provides non-clinical testing data to support this claim, rather than new clinical trials.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cowell Medi BioPlant System are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices (Nobel Biocare's Brånemark System and Implant Innovations, Inc. (3i) Dental Implant Systems). The performance criteria are therefore linked to matching or being functionally equivalent to these predicates across various attributes.

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

• Test Set (Non-clinical): For the mechanical fatigue and static shear testing, the document states: "BioPlant System production unit implant-abutment system samples, considered physically representative of the design most prone to worst-case mechanical loading following implantation, were subjected to testing per part 5 of ISO 14801."

  • The exact sample size (number of units tested) is not explicitly stated in the provided text, beyond "All samples survived" and "All samples exhibited acceptable yield points."
  • Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly. Given that the manufacturer is Cowell Medi Co., Ltd. from Busan, Korea, it's reasonable to infer the testing was likely conducted in Korea or by an accredited lab on behalf of the manufacturer. The testing adheres to ISO 14801, an international standard. The data is prospective in the sense that custom tests were performed on the BioPlant System samples to demonstrate performance against established standards.

• Test Set (Clinical): No new clinical test set was used for the BioPlant System itself. The submission explicitly states: "Cowell Medi perceives the adequacy of such existing documentation substantiates the exclusion of both animal and human clinical studies protocols or data." Instead, they rely on "Abundant, significant, peer reviewed documentation supporting the successful clinical performance of root-form endosseous dental implants and abutment systems exists." This refers to retrospective evidence from the wider body of literature and the predicate devices.

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

• Non-clinical Testing: For the mechanical and static shear testing, ground truth is established by objective engineering standards (ISO 14801) and the physical properties of the materials and design, not by expert consensus. There are no "experts" establishing unique ground truth in this context; rather, the tests measure objective performance metrics.
• Clinical Ground Truth: No new clinical ground truth was established by experts for the BioPlant System specifically. The submission relies on existing "peer-reviewed documentation" and the clinical history of the predicate devices. The "ground truth" for clinical performance, in this case, is derived from the established safety and effectiveness of similar devices in the medical literature.

4. Adjudication Method for the Test Set

• Non-clinical Testing: Not applicable. The mechanical and static shear tests have objective pass/fail criteria (e.g., survival after 5 million cycles, acceptable yield points, no fractures prior to yield). There's no human adjudication of ambiguous results.
• Clinical Testing: Not applicable, as no new clinical studies were performed.

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. The document describes a dental implant system, not a diagnostic AI device requiring multi-reader, multi-case studies or assessment of human reader improvement with AI assistance.

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

• Not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Non-clinical: Objective physical and mechanical standards (ISO 14801), laboratory measurements of fatigue resistance and yield strength.
• Clinical: The clinical ground truth for showing "successful osseointegration" and "firm and direct connection between the living bone and surface of the titanium implant" is based on the general body of "Abundant, significant, peer reviewed documentation" for root-form endosseous dental implants. This implies reliance on historical outcomes data and expert consensus within the dental community regarding the performance of similar, established devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set. The device design and manufacturing processes are likely informed by years of engineering knowledge and clinical experience with dental implants, rather than a quantifiable training dataset in the AI sense.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As stated above, this is not an AI device.

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The 3i Patient-Specific Dental Abutment and Overdenture Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support single and multiple tooth prostheses, in the mandible or maxilla. The prostheses can be screw or cement retained to the abutment.

The 3i Patient-Specific Dental Abutments and Overdenture Bars are designed to match individual patients.

This is a 510(k) premarket notification for a dental device, not an AI/ML medical device. As such, the document does not contain the information required to answer the questions regarding acceptance criteria and studies that prove the device meets them in the context of AI/ML performance.

The document primarily focuses on establishing substantial equivalence to predicate devices based on overall design and intended use, rather than presenting a performance study with acceptance criteria for an AI algorithm.

Therefore, most of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types for AI) is not applicable or present in this submission.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.

This 510(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted implants ≥ 10mm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.

The provided 510(k) summary for K030614 describes the acceptance criteria and supporting studies for the 3i Dental Implants, specifically for the expansion of indications to include immediate loading procedures in the mandible.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in a clear, tabulated format for the clinical performance. Instead, it relies on substantiating "clinical success" and "osseointegration" based on existing literature and previous clearances.

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

The submission primarily relies on a literature review of previously published clinical studies, rather than a single, dedicated prospective clinical trial for this specific 510(k) submission. Therefore, "test set" sample sizes are derived from these referenced studies.

• Tarnow et al.: 107 implants (in 10 edentulous cases).
• Testori et al.: 12 Osseotite implants (in 1 patient).
• Defrancq et al.: 417 Osseotite implants in 68 mandibular procedures; 309 Osseotite implants in 34 maxilla procedures.
• Ibanez and Jalbout: 87 Osseotite implants in 11 patients.
• Data Provenance: The studies are published clinical literature. The country of origin is not explicitly stated for all, but given the names and journals, they are likely international, possibly with an emphasis on European and North American research. All are retrospective analyses of cases or small prospective case reports/series.

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

This information is not provided. The summarized studies are clinical publications, and the ground truth (e.g., osseointegration, implant success/failure) would have been established by the clinicians/researchers involved in those individual studies based on standard dental and surgical assessment methods (clinical examination, radiographs, and for one study, histologic analysis). There is no mention of an independent panel of experts establishing a ground truth for a unified "test set" for this 510(k) specifically.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable in the context of this submission. Since the submission relies on published literature, there's no mention of a formal adjudication method for a specific test set. The outcomes in the referenced studies were assessed by the respective study authors.

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 for dental implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness is presented.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (dental implant), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the referenced clinical studies was primarily:

• Outcomes Data: Clinical success/failure, implant survival rates, absence of mobility, absence of periimplant radiolucency.
• Clinical Examination: Assessment of implant stability and health.
• Radiographic Examination: To check for periimplant radiolucency and bone levels.
• Histology/Pathology: Testori et al. specifically mention "histologic analysis after 4 months of occlusal loading" and "histomorphometric evaluation revealed 78%-85% bone-to-implant contact."

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning algorithm.

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

Not applicable. This is a medical device, not a machine learning algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The submission leverages a combination of non-clinical (mechanical) testing and a literature review of clinical studies to demonstrate that the 3i Dental Implants, when used for immediate loading, are "substantially equivalent" to predicate devices and clinically successful.

Non-clinical Testing:

• Mechanical tests (Static Load Compression, Cyclic Fatigue) were performed on 3i implants and the new single-piece abutment. These tests simulated biting and chewing forces and passed established criteria, showing the components' physical integrity. Insertion torque for the new abutment also passed, exceeding recommended levels.

Clinical Performance (Literature Review):
The submission relies on a review of existing clinical literature, specifically highlighting four studies:

• Tarnow et al. (1997): A case series involving various implant types (including 3i) for immediate loading in edentulous arches, reporting high osseointegration rates.
• Testori et al. (2001): A case report on Osseotite implants in the mandible, demonstrating clinical and histologic osseointegration during immediate loading, with good bone-to-implant contact.
• Defrancq et al. (2002): A report on successful immediate loading techniques using Osseotite implants in both maxilla and mandible, with very low implant loss rates (e.g., 0.48% in mandibular procedures).
• Ibanez, JC, Jalbout,ZN (2002): A two-year follow-up study on Osseotite implants for immediate loading, reporting 100% success with no implant mobility or periimplant radiolucency.

The submission argues that these studies, along with prior animal studies (K983347) and general current clinical practice, provide sufficient evidence of "substantial clinical success with early loading" for implants similar in design and materials to the 3i implants, thereby supporting the expanded indication for immediate loading. The overall argument for acceptance is based on the substantial equivalence of the 3i implants to other legally marketed devices indicated for immediate loading, supported by safety and performance data from both non-clinical testing and clinical literature review.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for for the patient.

Endosseous implant system consists of implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for dental implant abutments, intended to demonstrate substantial equivalence to predicate devices already on the market. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria.

The document discusses:

• Predicate Devices: Lists specific 510(k) numbers for previously cleared dental implant systems.
• Device Description: Describes the endosseous implant system, focusing on pre-machined angulated abutments (15 and 25-degree) and wide-body abutments (4, 5, and 6 mm platform diameters).
• Intended Use: To facilitate the prosthetic phase and installation of a prosthesis for the patient.
• Technology Characteristic Summary: States that design, material, manufacturing process, sterilization, geometry, and service are similar to predicate devices. Materials used are ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. It also mentions compliance with GMP guidelines.

Therefore, I cannot provide the requested information about acceptance criteria or a study demonstrating device performance because it is not present in the provided text. The document's purpose is to establish substantial equivalence for market clearance, not to detail performance studies against specific acceptance criteria.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.

system consists of Endosseous implant implants, tools and abutments. This submission includes pre-machined angulated abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for a dental implant system. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, manufacturing process, and intended use. It does not present performance data or clinical study results in the manner requested.

Therefore, I cannot provide the requested information.

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NEW INDICATION FOR USE: SINGLE STAGE SURGERY USING DEVICES ORIGINALLY INDICATED FOR A TWO-STAGE SURGICAL PROCEDURE.

The 3i Implant System is designed for use in dental implant surgery. It includes a variety of types and sizes of specially designed bone implantable titanium and titanium alloy implants, including Standard and Self-Tapping Threaded Screw-Type and cylindrical press-fit implants with Titanium Plasma-Sprayed or Hydroxylapatite coatings. These implants are surgically inserted into the upper and/or lower jawbones.
Temporary Healing, Emergence Profile (EP) Abutments were designed to be attached to the implant at a second stage surgical procedure, after a sufficient healing time for the implant/bone interface to form. Healing abutments were placed to help form the soft tissues to the proper diameter of the final restoration, creating a natural Emergence Profile of the prosthesis.

PROPOSED NEW INDICATION FOR USE: Most clinicians recognize the need to protect the implant from premature loading throughout the required healing period. They also recognize the benefits of a single surgical procedure in cases that provide adequate protection of the implant/ healing abutment; such as with use of a modified, soft relined denture or a bridge, preventing mastication forces from affecting the implanted devices.
In such cases, clinicians have used "Single-Stage" implant systems such as "The ITI Dental Implant System" distributed by The Straumann Company or, the "Immediate-Load Implant" distributed by Sargon Enterprises, Inc., as well as others, or have utilized two-stage implant systems offering temporary healing abutments, such as the 3i Implant/EP System.

A single-stage surgical process by which a 3i implant is placed into the bone and a 1 or 2 piece (EP) Temporary Healing Abutment is immediately attached to the implant, may be considered in those cases where the implant and healing abutment can be adequately protected from mastication forces throughout the healing period, by opposing dentition, denture or bridge that if required, may be modified to provide such protection.

The EP Temporary Healing Abutment may be a one or two piece abutment and, will be removed after the implant is firmly anchored into the healed implant site, without surgically altering the soft tissues.

Upon placement of the implant, instead of a cover screw, a Temporary (EP) Healing Abutment, that is of suitable height for the soft tissues, is secured to the implant. The mucoperiosteal flaps are then sutured closed around the healing abutment. During the healing phase, the soft tissues form to the diameter and contours of the healing abutment, forming the tissues to the "more natural emergence profile". This benefits both patient and surgeon in that only one surgical procedure is required. Both bone and soft tissues heal during the same time period, shortening the entire implant/reconstruction process by several months and reducing the chance for infection or other complications attributed to surgery.

Upon proper healing, impressions are taken using the 3i EP Impression system (K934126), and temporary or final prosthesis fabricated. No further surgery is required.

The 3i implant system was submitted in a Pre-Market Notification that has since been amended and modified by subsequent submissions. The 3i implant system was originally determined substantially equivalent on or about May 11, 1988. For the purpose of this submission, all 3i implants and One and Two Piece Temporary Healing, Emergence Profile (EP) Abutments are to be considered.

The 3i Implant System is designed for use in dental implant surgery. It includes a variety of types and sizes of specially designed bone implantable titanium and titanium alloy implants, including Standard and Self-Tapping Threaded Screw-Type and cylindrical press-fit implants with Titanium Plasma-Sprayed or Hydroxylapatite coatings. These implants are surgically inserted into the upper and/or lower jawbones.
Temporary Healing, Emergence Profile (EP) Abutments were designed to be attached to the implant at a second stage surgical procedure, after a sufficient healing time for the implant/bone interface to form. Healing abutments were placed to help form the soft tissues to the proper diameter of the final restoration, creating a natural Emergence Profile of the prosthesis.

The EP Temporary Healing Abutment may be a one or two piece abutment and, will be removed after the implant is firmly anchored into the healed implant site, without surgically altering the soft tissues.

This 510(k) summary does not contain a formal acceptance criteria section with a study designed to prove the device meets those criteria, as it is primarily focused on demonstrating substantial equivalence for a new indication for use of an already cleared device, rather than a new device requiring de novo validation.

The new indication for use is for single-stage surgery using existing 3i implants and temporary healing (EP) abutments, which were originally cleared for a two-stage procedure. The submission argues that this single-stage approach is substantially equivalent to other already cleared single-stage implant systems.

Therefore, the requested information about acceptance criteria, performance tables, sample sizes, ground truth establishment, and MRMC studies is not explicitly available or applicable in the provided text in the manner typically seen for a new device's performance validation.

However, based on the provided text, we can infer the "acceptance criteria" through the conditions under which the new indication is considered safe and effective, and the "study" is the comparison to substantially equivalent devices and the known clinical studies referenced for implant integration.

Here's an attempt to structure the information based on your request, highlighting what is implicitly stated or not directly provided:

1. Table of Acceptance Criteria and Reported Device Performance

As there are no explicit quantitative acceptance criteria or a dedicated performance study for this specific new indication, this section will define inferred "acceptance criteria" based on the described conditions for successful single-stage surgery and the comparative nature of the submission. "Reported device performance" would refer to the general understanding of 3i implant and healing abutment behavior, coupled with the claim of substantial equivalence.

• Use of a modified, soft relined denture
• Use of a bridge
  This protection prevents mastication forces from affecting the implanted devices. |
  | Proper Soft Tissue Healing and Formation: Soft tissues should heal around the healing abutment to the proper diameter and contours, forming a natural emergence profile. | "During the healing phase, the soft tissues form to the diameter and contours of the healing abutment, forming the tissues to the 'more natural emergence profile'." This is a described benefit and expected outcome of using the EP Temporary Healing Abutments in a single-stage procedure. |
  | Reduced Surgical Procedures and Healing Time: The procedure should effectively shorten the overall implant/reconstruction process by consolidating bone and soft tissue healing into one period. | "Both bone and soft tissues heal during the same time period, shortening the entire implant/reconstruction process by several months and reducing the chance for infection or other complications attributed to surgery." This is a stated benefit and functional outcome. |
  | Substantial Equivalence to Predicate Single-Stage Systems: The 3i single-stage protocol should perform comparably to legally marketed single-stage systems in terms of safety and effectiveness within their indications. | The submission claims substantial equivalence to "The ITI Dental Implant System" (Straumann Company) and the "Immediate-Load Implant" (Sargon Enterprises, Inc.) for single-stage surgical procedures, within the safety conditions outlined (e.g., no immediate loading recommended for 3i). The 3i system is described as offering advantages in abutment choices. |

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

• Sample Size: Not applicable/provided. This submission does not describe a new clinical study. It refers to "well known clinical studies" for general implant integration, but no specific test set or sample size is detailed for the new indication.
• Data Provenance: Not applicable. The submission leverages existing knowledge about 3i implants and compares the proposed single-stage approach to existing, cleared single-stage systems on the market. It's a regulatory argument of substantial equivalence based on engineering principles and clinical understanding, not a new clinical trial.

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

• Not applicable. There was no "test set" and thus no independent ground truth established by experts specifically for this submission. The basis for safety and effectiveness is established by the prior clearance of 3i devices, general scientific understanding of dental implants, and the regulatory pathway of substantial equivalence to predicate devices which have already undergone such scrutiny.

4. Adjudication Method for the Test Set

• Not applicable. No test set was used requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The submission focuses on the safety and effectiveness of the single-stage surgical protocol using existing devices by comparing it to predicate devices, not on the performance of human readers with or without AI assistance.

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 (dental implant and abutments) and a surgical protocol, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" implicitly relied upon is:
  • Expert Consensus/Established Clinical Knowledge: The general understanding of successful osseointegration, proper surgical techniques, patient selection, and potential complications in dental implantology, as described in medical literature and accepted clinical practice.
  • Regulatory Clearance of Predicate Devices: The established safety and effectiveness of the 3i implant system (through its original 510(k) clearance in 1988) and the predicate single-stage implant systems (ITI Dental Implant System and Immediate-Load Implant by Sargon Enterprises, Inc.) previously cleared by the FDA. The submission argues that the 3i device, used in a single-stage protocol under specific conditions, will be as safe and effective as these predicate devices.

8. The Sample Size for the Training Set

• Not applicable/provided. No "training set" in the context of machine learning or a specific clinical trial is described. The development of the 3i implant system and the understanding of its performance would have been based on historical clinical data, scientific literature, and engineering principles, but no specific training set size is mentioned.

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

• Not applicable. As there is no described training set for an AI/algorithm, this question is not relevant to the provided 510(k) summary. The "ground truth" for the original 3i implant system's development and clinical understanding would have been established through a combination of biomechanical testing, animal studies, and human clinical trials prior to its initial clearance. However, this submission does not detail those historical processes.

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The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the proBthetic phase and installation of the programs of the program and 824 U.S. Highway 1, Suite 370 1499 W. Palmetto Park Road Boca Raton 33486-3311 N. Palm Beach, Florida 33408 (407) 392-4747 (407) 627-5560 FAX (407) 392-8320 FAX (407) 627-4214 "Tomorrow's Technology Today"

Endosseous implant system consists of implants, tools and This submission includes pre-machined angulated abutments. abutments less than 30 degrees, specifically 15 and 25-degree abutments are included. In addition, in the wide-body abutment series, a series of one and two-piece prosthetic abutments are included in 4, 5 and 6 mm. platform diameters. These devices are similar in their use in that they are placed on top of the implant fixtures after the appropriate integration phase and prosthetic attachments are fabricated to these abutments.

This document is a 510(k) summary for an endosseous implant system, specifically focusing on wide body and pre-angled abutments. It primarily establishes substantial equivalence to predicate devices and does not describe a clinical study or performance testing against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics cannot be found in this document.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance

• None stated: The document does not define specific quantitative acceptance criteria or report on device performance against such metrics. Its focus is on demonstrating substantial equivalence to predicate devices.

Study Details

As no specific study is described in this 510(k) summary, the following information is not available:

1. Sample size used for the test set and the data provenance: Not applicable.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method for the test set: Not applicable.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used: Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Information that is available in the document:

• Device Description:
  • Consists of implants, tools, and pre-machined angulated abutments (15 and 25-degree).
  • Includes wide-body abutments of one and two-piece prosthetic designs with 4, 5, and 6 mm platform diameters.
  • Placed on top of implant fixtures after integration.
• Intended Use:
  • Similar to other implant systems.
  • To facilitate the prosthetic phase and installation of prostheses.
• Technology Characteristic Summary:
  • Material, manufacturing process, gamma sterilization, design, geometry, and services are similar to predicate devices.
  • Materials: ASTM standard B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5.
  • GMP guidelines are in place and have been inspected by the FDA Office of Compliance.
• Predicate Devices:
  • General: Dental Imaging Associates (K902433, K902434, K902435), Implant Innovations (K932123).
  • For Wide Body: Nobelpharma (K925766, K934826, K934495), Implant Innovations (K933969, K934126, K933462).

In summary, this document serves as a regulatory submission demonstrating substantial equivalence through comparison to existing devices, rather than presenting data from a clinical performance study with predefined acceptance criteria.

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