(89 days)
CONELOG® Titanium base CAD/CAM
- Implant-prosthetic titanium abutment for CONELOG® implants with connection, as a bonding base for hybrid abutments.
- The Titanium base CAD/CAM for implant Ø 3.3 mm is designed only for hybrid abutments in the area of the upper lateral incisors and lower central and lateral incisors.
CONELOG Titanium base CAD/CAM is an abutment designed to be used with the Sirona CAD/CAM System in Coris ZI meso L and meso S to fabricate a hybrid abutment with an angle up to 20°.The Titanium base CAD/CAM is available in four implant platform sizes (3.3 mm 3.8 mm, 4.3 mm, and 5.0 mm), two gingival heights (0.8 mm or 2.0 mm) and is supplied with the corresponding screw. All design parameters are according to the cleared Sirona CAD/CAM System parameters.
This document is a 510(k) summary for the CONELOG® Titanium base CAD/CAM. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on performance testing designed to demonstrate mechanical integrity under relevant dental conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Integrity | Passed static and dynamic compression-bending testing according to ISO 14801. |
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 does not specify the exact sample size for the non-clinical testing. It only states that "non-clinical testing data submitted" was used. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
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 submission for a physical implant component, not an AI or imaging-based diagnostic tool. Therefore, there is no "ground truth" in the diagnostic sense, and no experts were used to establish such. The "ground truth" for this type of device is its mechanical robustness and compliance with established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an imaging or diagnostic study requiring adjudication for ground truth.
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 a submission for a physical dental implant component, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a physical dental implant component, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the successful completion of established mechanical performance tests (ISO 14801) designed to simulate in-vivo conditions. The device is expected to withstand specified static and dynamic forces without failure, demonstrating its structural integrity and safety.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI-based device, so there is no training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.)