(119 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
The purpose of this submission is to expand the Neodent Implant System - GM Line components cleared under K163194, which included dental implants with a Morse taper abutment interface (called Grand Morse, or GM), mating abutment screws, and other associated components. This submission includes the GM Exact Co-Cr Abutment for Crown and the GM Equator Attachment. The subject device components mate exclusively with the GM implants cleared in K163194.
The GM Exact Co-Cr Abutment for Crown is provided in three sizes to fit the prosthetic diameter sizes of the GM implants cleared in K163194. The subject device abutments consist of a Co-Cr alloy component that interfaces directly to the implant and a cvlinder of polyoxymethylene (POM) for fabrication of a cast prosthesis by a burn-out technique. The subject device abutments are provided in three (3) sizes to match the various platforms of the mating GM implants: 3.5/3.75 mm platform diameter, 4.0/4.3 mm platform diameter, and 5.0/6.0 mm platform diameter. The subject device abutments are for single-unit prosthetic restorations only. The final prosthetic restoration may be cement-retained or screw-retained.
The GM Equator Attachment abutments are straight, ball-type abutments for the attachment of full or partial overdentures. GM Equator Attachments are provided in five gingival heights (1.5, 2.5, 3.5, 4.5, and 5.5 mm), and may be used with all GM implant diameter sizes cleared in K163194.
The subject device GM Exact Co-Cr abutments are made of Co-Cr alloy conforming to ASTM F1537, with mating abutment screws made of titanium alloy conforming to ASTM F136. The GM Equator Attachments made of titanium alloy conforming to ASTM F136 with a TiN coating identical to the TiN coating cleared in K133696.
This document describes the Neodent Implant System - GM Line, specifically introducing new abutment components. Based on the provided text, the acceptance criteria and study information are focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The document mainly uses non-clinical performance data (biocompatibility, sterilization validation, shelf-life, bacterial endotoxin testing) to support this claim.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device (e.g., accuracy, sensitivity, specificity, or clinical outcomes). Instead, the performance data presented is aimed at demonstrating the device's characteristics are comparable to predicate devices. The "performance" is primarily shown through a comparison of technological characteristics and non-clinical testing results to existing standards and predicate devices to establish substantial equivalence.
| Acceptance Criterion | Reported Device Performance (as demonstrated by comparison/testing) |
|---|---|
| Biocompatibility | Demonstrated through testing according to ISO 10993-5, ISO 10993-12, and ISO 10993-18 for the GM Exact Co-Cr Abutment for Crown. Biocompatibility of titanium alloy components referenced to K163194 and K133696. |
| Sterilization Validation | Performed according to ISO 17665-1, ISO TS 17665-2, ISO 11135, and ISO 10993-7. |
| Sterile Barrier Shelf Life | Performed on real-time aged samples (referenced from K163194), including seal strength, helium leak detection, and sterility testing of package contents. |
| Bacterial Endotoxin Testing | Performed using methods described in AAMI / ANSI ST72. |
| Material Composition | GM Exact Co-Cr Abutment for Crown: Co-Cr alloy conforming to ASTM F1537; Mating abutment screws: Ti-6Al-4V alloy, ASTM F136. GM Equator Attachments: Ti-6Al-4V alloy, ASTM F136 with TiN coating. (Demonstrates equivalence or compliance to accepted material standards). |
| Mechanical Design/Interface | Subject device abutments have identical implant interface design to Neodent GM implants cleared in K163194. Morse taper connection with internal hex prosthetic indexing. Straight (0°) angles only. |
| Intended Use | Functional and esthetic rehabilitation of the edentulous mandible or maxilla, consistent with predicate devices. |
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 focuses on non-clinical testing and refers to standards. It does not specify "sample sizes" in the context of clinical test sets or patient data.
- Sample size for testing: Not explicitly stated for each non-clinical test (e.g., number of abutments tested for biocompatibility or number of packages for shelf-life). However, regulatory standards (like ISO 10993, ISO 17665-1) inherently require specific sample sizes for valid testing.
- Data Provenance: The manufacturer is JJGC Indústria e Comércio de Materiais Dentários S.A. based in Curitiba, Paraná, Brazil. The non-clinical testing would presumably have been conducted by or commissioned by this company, possibly in Brazil or by certified labs internationally. The data is non-clinical, not from human subjects, hence "retrospective or prospective" does not directly apply in the clinical sense.
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 information is not applicable. The provided document details the submission for new components of an existing dental implant system, demonstrating substantial equivalence through non-clinical testing (biocompatibility, sterilization, material specifications). It does not involve diagnostic imaging or other subjective assessments that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable, as there is no clinical test set requiring adjudication in the context of diagnostic interpretation or outcomes.
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 a dental implant system (hardware), not a diagnostic AI device. Clinical data was explicitly not submitted: "Clinical data were not submitted in this premarket notification." Therefore, no MRMC study or AI-related comparative effectiveness was performed or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a dental implant system (hardware), not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" or reference for evaluating compliance consists of:
- International Standards: ISO 10993 series (biocompatibility), ISO 17665-1, ISO TS 17665-2, ISO 11135, ISO 10993-7 (sterilization), AAMI / ANSI ST72 (bacterial endotoxin testing).
- Material Standards: ASTM F1537 (Co-Cr alloy), ASTM F136 (Ti-6Al-4V alloy).
- Predicate Device Characteristics: Comparison of physical dimensions, design principles, intended use, and materials to established predicate devices (K163194, K101207, K121843, K133696) to demonstrate substantial equivalence.
There is no "ground truth" in the sense of clinical expert consensus, pathology, or outcomes data, as clinical data was not submitted.
8. The sample size for the training set
This information is not applicable. This is a submission for a physical medical device (dental implant components), not a machine learning or AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for an algorithm.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)