(96 days)
The Zimmer Contour Provisional Coping is for use with a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
The Short Provisional Coping is for use with a Short Hex-Lock Abutment to prevent irritation of soft tissue due to rubbing against the restorative area of the abutment or implant, to prevent material from lodging in any undercuts or openings, and for fabricating a cement-retained provisional restoration. Use of the provisional coping is not to exceed 180 days.
The Contour Provisional Coping is a smooth plastic cap that fits passively over the cone of a Hex-Lock Contour Abutment or a Zimmer One-Piece Implant and mates with the margin of the abutment or implant abutment section. Each passive fit cap is affixed to the abutment/implant cone with appropriate dental adhesive material selected by the clinician.
The Short Provisional Coping is a tan, textured, plastic cap that fits passively over the cone of a Hex-Lock® Short Abutment and mates with the margin of the abutment.
Here's an analysis of the provided text regarding the Zimmer Dental device, broken down into the requested categories:
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance | Reported Device Performance |
|---|---|---|
| Intended Use | To prevent irritation of soft tissue, prevent material lodging, and for fabricating a cement-retained provisional restoration (use not to exceed 180 days). | The device's indications for use are identical to the predicate devices. |
| Material Equivalence | PEEK material to demonstrate improvement in functional performance over predicate materials (Ultem and PMMA). | The new device uses PEEK, which is stated to "demonstrates an improvement in functional performance compared to Ultem and PMMA." |
| Design Equivalence | Maintain similar fit and design features to predicate devices. | "Modified devices are equivalent in intended use, design, and materials." Specific design features (e.g., "Mates uniquely with shape of Contour abutment," "Has indexing / anti rotation feature") are maintained as per the comparison table. |
| Safety and Efficacy (Overall) | As safe and effective for its intended use and performs as well or better than the predicate device(s). | "Based on our analysis, the device is substantially equivalent to the predicates and it is considered that the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s)." |
| New Risks | No new safety or efficacy concerns and no new risks identified through modifications. | "modifications... do not bring up new concerns regarding safety and efficacy and no new risks have been identified." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. No "test set" in the context of clinical or performance data was used for a traditional AI or diagnostic device evaluation. This submission relies on non-clinical testing and comparison to predicate devices, not clinical data or a test set of patient cases.
- Data Provenance: Not applicable. No clinical data or patient data was used.
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. No ground truth establishment by experts for a test set was performed. The evaluation is based on material properties and design comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication was used.
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
- No MRMC comparative effectiveness study was done. This is a submission for a physical dental device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the performance and safety established by the predicate devices and the non-clinical testing demonstrating material properties.
8. The sample size for the training set
- Not applicable. No training set was used. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set or associated ground truth establishment was performed.
Summary of the Study Proving Device Meets Acceptance Criteria:
The Zimmer Dental submission (K113092) for the Zimmer® Contour Provisional Coping and Zimmer® Short Provisional Coping does not involve a study in the traditional sense of clinical data collection, AI algorithm evaluation, or human reader performance.
Instead, the "study" demonstrating the device meets acceptance criteria is a non-clinical equivalence study based on design, material, and intended use comparison to legally marketed predicate devices.
- Non-Clinical Testing: "Non-clinical test data was not used to support the decision of safety and effectiveness. Clinical literature and material mechanical prosperities indicated that the device is strong enough to withstand the anticipated forces and demonstrated improvements over the predicate devices."
- Equivalence Argument: The core of the submission is the argument of "substantial equivalence" to five predicate devices. This argument is built upon:
- Identical Indications for Use: The new devices share the exact same intended uses as their predicates (preventing soft tissue irritation, material lodging, and fabricating cement-retained provisional restorations for up to 180 days).
- Material Improvement: The new devices utilize PEEK (polyether ether ketone), which is stated to "demonstrate an improvement in functional performance compared to Ultem and PMMA" used in some predicate devices. This material change is presented as a benefit without introducing new risks.
- Maintained Design Characteristics: The comparison tables explicitly show that the fit (e.g., "Mates uniquely with shape of Contour abutment") and design features (e.g., "Has indexing / anti rotation feature") are maintained across the new and predicate devices.
- Manufacturing Process: The modified devices are manufactured using the "same process."
- Conclusion: The manufacturer concluded that "the new device is as safe and effective for its intended use and performs as well or better than the predicate device(s)" based on this non-clinical comparison and the improved material. The FDA concurred with this assessment, granting 510(k) clearance by finding the device "substantially equivalent."
§ 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.)