(134 days)
Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non occlusal loading of provisional restorations. The prosthesis will be mechanically retained to the abutment system.
The Certain® BellaTek™ Provisional Abutment is a two piece temporary healing abutment that consists of a machined provisional titanium alloy (6AL-4V) post, a PEEK provisional cap, and a machined stainless steel (316L) retaining screw with gold plating.
Acceptance Criteria and Device Performance Study for Certain® BellaTek™ Provisional Abutment (K130310)
The Certain® BellaTek™ Provisional Abutment is a two-piece temporary healing abutment designed to support a single prosthesis for up to 180 days during endosseous and gingival healing, with non-occlusal loading. The device's performance was evaluated through non-clinical testing to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Standard/Test/FDA Guidance | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Static Bend | ISO 14801 | Pass (withstand specified static load) | Passed |
| Fatigue | ISO 14801 | Pass (withstand specified cyclic loading) | Passed |
| Snap on/off Force Testing | N/A | Adequate force for secure retention and easy removal | Passed |
| Screw Torque | N/A | Maintain specified screw torque without failure | Passed |
| Comparative Static Bend/Fatigue | ISO 14801 | Equal to or better than predicate devices | Exceeds (K060291 predicate) |
Note: The specific quantitative acceptance values for "Pass" and "Adequate" are not provided in the summary but are implied to be met for FDA clearance. The "Exceeds" performance for comparative static bend/fatigue indicates the new device performed better than at least one predicate.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated for each test (Static Bend, Fatigue, Snap on/off Force, Screw Torque). The summary implies standard engineering and mechanical testing methodologies were applied, which typically involve testing multiple samples to statistical significance.
- Data Provenance: The data is derived from non-clinical (laboratory) testing conducted by the manufacturer, BIOMET 3i™. The country of origin for the data is not specified but is presumably the United States, where the manufacturer is located. The data is retrospective in the sense that it was collected and analyzed for this 510(k) submission, not as part of an ongoing prospective clinical trial.
3. Number of Experts and their Qualifications for Ground Truth
- This device clearance did not involve a human expert-based ground truth establishment for the test set. The evaluation was based on non-clinical mechanical testing.
4. Adjudication Method for the Test Set
- Not applicable, as the evaluation was based on non-clinical mechanical testing, not human-reviewed data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is a mechanical component (dental abutment), and its performance is assessed through physical testing rather than algorithmic interpretation by human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
- Not applicable. The device is a physical medical device, not an algorithm or software. Its performance is assessed through its physical characteristics and mechanical integrity.
7. Type of Ground Truth Used
- The ground truth for the device's performance was established through objective measurements and pass/fail criteria defined by recognized international standards (ISO 14801) and internal engineering specifications for mechanical properties (e.g., static bend strength, fatigue life, retention forces, screw torque).
8. Sample Size for the Training Set
- Not applicable. This device is a physical product, not an AI/ML algorithm that requires a "training set" of data.
9. How Ground Truth for Training Set Was Established
- Not applicable. As above, no training set was involved.
§ 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.)