(146 days)
The Biodenta Customized Abutment - Hybrid is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.
The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems:
Biodenta, Bone Level and Tapered B1: 3.5 mm; B2: 4.1, 4.8, 6.0 mm
Nobel Biocare, Nobel Replace straight and tapered NP: 3.5 mm; RP: 4.3 mm; WP: 5.0 mm; 6.0: 6.0 mm
Nobel Biocare, NobelActive NP: 3.5 mm; RP: 4.3, 5.0 mm
Biomet 3i, Certain Internal 3.4: 3.25, 4.0 mm; 4.1: 4.0, 5.0 mm; 5.0: 5.0, 6.0 mm; 6.0: 6.0 mm
Dentsply, Astra Tech OsseoSpeed 3.5/4.0: 3.5, 4.0 mm; 4.5/5.0: 4.5, 5.0 mm
Straumann, Bone Level NC: 3.3 mm; RC: 4.1, 4.8 mm
Zimmer, Screw Vent and Screw Vent Tapered 3.5: 3.3, 3.7, 4.1 mm; 4.5: 4.7 mm; 5.7: 6.0 mm
The Biodenta Customized Abutment - Hybrid is a two-piece abutment, which contains a premanufactured (stock) Titanium-Base and a Zirconium coping and/or crown that is designed by a dental technician using CAD software and manufactured at Biodenta milling centers.
The Biodenta Customized Abutment - Hybrid utilizes an Abutment Screw for abutment retention. The final cement retained restoration is constructed in the lab according to the dentist's specifications.
The Biodenta Customized Abutment - Hybrid is compatible with the following dental implant systems: Biomet 3i, Certain Internal; Dentsply, AstraTech OsseoSpeed; Zimmer, Screw Vent; Nobel Biocare, Nobel Biocare, NobelReplace; Straumann, Bone Level; Biodenta, Bone Level and Tapered
The Titanium-Base and the Abutment Screw of the Biodenta Customized Abutment - Hybrid are made of biocompatible Ti-6AI-4V ELI conforming to ISO 3852-3 and ASTM F136.
The Zirconium coping and/or crown of the Biodenta Customized Abutment - Hybrid are made of biocompatible ZrO2 conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
The provided text is a 510(k) premarket notification for a medical device called the "Biodenta Customized Abutment - Hybrid." This document is a regulatory submission to the FDA proving substantial equivalence to existing devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria.
Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the format requested by the user. The information provided focuses on demonstrating substantial equivalence through non-clinical testing (fatigue testing and engineering/compatibility analysis) and comparison to predicate devices, rather than a clinical trial with acceptance criteria for device performance.
However, I can extract the information that is present concerning non-clinical testing:
Device: Biodenta Customized Abutment - Hybrid
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission and not a clinical study with performance acceptance criteria, the document does not present a table of acceptance criteria and reported device performance directly. Instead, it states that "Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff. The worst case scenario for the Biodenta Customized Abutment - Hybrid and implant was tested. The results show that the Biodenta Customized Abutment - Hybrid has sufficient mechanical strength for the intended clinical application."
This implies that the acceptance criteria for fatigue testing were met, but the specific numerical criteria and comparative results are not detailed in this summary.
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 mentions "Fatigue testing" and "Engineering and Compatibility analysis" as non-clinical testing data.
- Sample Size: Not specified for either fatigue testing or compatibility analysis.
- Data Provenance: Not specified. As the submitting company is "Biodenta Swiss AG" based in Switzerland, it's plausible the testing was conducted in Switzerland or a country with recognized standards. This information is typically found in the full test reports, not the summary.
- Retrospective or Prospective: Not applicable for non-clinical, in-vitro testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the testing described is non-clinical (mechanical and compatibility analysis), not a study requiring expert clinical adjudication of ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as the testing described is non-clinical.
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 device is a dental abutment, 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 device is a dental abutment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the non-clinical tests:
- Fatigue Testing: "Ground truth" would be established by the industry standard (ISO 14801:2007) indicating acceptable mechanical loads and cycles without failure.
- Compatibility Analysis: "Ground truth" would be established by engineering specifications and physical fit/interaction with specified implant systems.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI device.
§ 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.)