(132 days)
CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.
Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
This document describes the premarket notification (510(k)) for the CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the same way as for a novel device or a clinical trial.
However, based on the provided text, we can infer the equivalence criteria and the studies performed to demonstrate substantial equivalence, which serves a similar purpose in the 510(k) process.
Here's the breakdown of the information related to acceptance criteria and supporting studies, interpreted within the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission, the "acceptance criteria" are predominantly related to demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material. The "reported device performance" is the comparison made against the predicate devices.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Subject Device vs. Predicate) |
|---|---|
| Similar Indications for Use | Both subject device and predicate support occlusal screw-retained prosthetic restorations in conjunction with dental implants. The difference in language does not change the intended use. |
| Similar Design (Technological Characteristics) | Prosthesis Attachment: Both are screw-retained. |
| Abutment Platform Diameter: Subject (3.3 - 6.0 mm) overlaps with Primary Predicate (3.5 - 4.6 mm) and Reference Predicates (3.3 - 6.0 mm). | |
| Abutment Angle: Subject (Straight to 30°) matches Primary Predicate (Straight to 30°) and Reference Predicates (Straight to 20°/30°). | |
| Availability of Straight and Angled Abutments: Both have straight and angled options (17° and 30°). | |
| Gingival Heights: Similar multiple gingival heights (e.g., subject: 0.5, 2.0, 4.0 mm, predicate: 1.0 - 4.0 mm). | |
| Indexing Orientations: Both include Type A and B indexing. | |
| Titanium Cap: Both subject and primary predicate have a titanium cap for temporary or permanent restorations. | |
| Similar Materials | Abutment Material: Subject device uses Ti-6AL-4V ELI, while Primary Predicate uses Ti-6AL-7Nb. Reference Predicates also use Ti-6AL-4V ELI. The document suggests these are "similar materials." |
| Similar Sterilization Methods | Both subject and predicate devices are sterilized using similar methods. |
| Similar Packaging Materials | Both subject and predicate devices are packaged in similar materials. |
| Satisfactory Non-Clinical Performance (Specific Tests) | Sterilization Validation: ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2. |
| Biocompatibility: ISO 10993-1. | |
| Mechanical Performance: Static and dynamic compression-bending testing according to ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). |
2. Sample Size Used for the Test Set and Data Provenance
For a 510(k) submission focused on substantial equivalence through non-clinical testing, there isn't a "test set" in the traditional sense of a clinical study with a patient cohort.
- Non-Clinical Tests: The sample sizes for each non-clinical test (sterilization, biocompatibility, mechanical fatigue) would be determined by the specific ISO standards referenced (e.g., ISO 14801 for fatigue testing often specifies sample sizes for statistical significance). These details are not provided in the document.
- Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Altatec GmbH). The country of origin for the data is Germany (manufacturer's location). The data is prospective in the sense that these tests were conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests is based on the specific requirements and methodologies outlined in the referenced ISO standards.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data were not submitted in this premarket notification."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical dental abutment and not an AI algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by the established international standards (ISO standards) referenced. For example:
- For sterilization, the ground truth is achieving the specified Sterility Assurance Level (SAL) per ISO 11137.
- For biocompatibility, the ground truth is demonstrating no unacceptable biological responses based on ISO 10993-1.
- For dynamic fatigue, the ground truth is withstanding specified loads for a defined number of cycles, as per ISO 14801.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical dental abutment and not an AI algorithm.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as the device is a physical dental abutment and not an AI 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.)