(130 days)
The Biodenta Customized Abutment 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 is compatible with the following implant systems:
-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant. XiVA Implant. 3i:Certain Internal Connect Type: Astra: Osseospeed Implant. Osseospeed TX implant; Biohorizons: Internal Implant System, Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.
-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered, Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
Biodenta Customized Abutments are titanium abutments designed to be used in coniunction with specific dental implants utilizing the Biodenta customized abutment screws to secure the abutment to the implant. In combination with the implant, the abutments support single or multi-unit cement-retained restorations in the maxillary and/or mandibular arch.
The abutment is milled using computer-assisted technology that enables the creation of final abutments that are manufactured with specific geometry. The abutment is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136). The abutment screw and interface is made from titanium grade Ti-6AL-4V ELI (meets ASTM standard F-136).
The Biodenta Customized Abutment is compatible with the following implant systems:
-Internal hex systems with flat-to-flat dimensions of 1.78mm or greater: Friadent: FRIALIT Implant, XiVA Implant, 3i:Certain Internal Connect Type; Astra: Osseospeed Implant. Osseospeed TX implant: Biohorizons: Internal Implant System. Tapered Internal Implant System, Single-Stage Implant System; Lifecore: Lifecore RENOVA Internal Hex Implant System; Zimmer: Tapered Screw-Vent Implant System, Screw-Vent Implant System, AdVent Implant System.
-Nobel Biocare Replace: NobelReplace Straight, NobelReplace Tapered; Replace Select Tapered. Replace Select Straight; for the NP, RP, WP and 6.0 implants. -External hex systems with flat-to-flat dimensions of 2.4mm or greater: Nobel Biocare Branemark, 3i, BioHorizons, and Lifecore.
Here's a breakdown of the acceptance criteria and the study information for the Biodenta Customized Abutment, based on the provided 510(k) summary:
This device is a physical medical device (dental implant abutment) and therefore does not involve AI/ML technology. The questions regarding AI/ML-specific study design (such as MRMC studies, standalone algorithm performance, training/test set details, expert ground truth establishment for AI/ML models) are not applicable to this submission.
The study described is a non-clinical fatigue testing study to demonstrate mechanical strength and compatibility, and a substantial equivalence comparison to predicate devices, both standard for this type of physical device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Strength & Compatibility: Sufficient mechanical strength for intended clinical application and compatibility with specified implant systems, as per ISO 14801. | "Fatigue testing was conducted according to ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants with the worst case scenario for each Biodenta Customized Abutment connection platform. These results show that Biodenta Customized Abutment have sufficient mechanical strength for their intended clinical application and are compatible with the implant systems for which they are intended." |
| Substantial Equivalence: Equivalent to predicate devices in intended use, material composition (with noted exceptions for zirconia predicates), fundamental scientific technology, principles of operation, and basic design, raising no new questions of safety or effectiveness. | "Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Customized Abutment is substantially equivalent to the predicate devices in intended use, material composition (except to K072241 and K063734 which are zirconia), fundamental scientific technology, princibles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for Biodenta Customized Abutment." |
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 explicitly stated as "test set" in the context of clinical data. For the fatigue testing, it's typically understood that a sufficient number of samples (representing the "worst case scenario" for each connection platform) would have been used to meet ISO 14801 requirements. The specific number of abutments tested is not provided.
- Data Provenance: The fatigue testing is non-clinical laboratory testing, not human data. The testing was conducted to ISO 14801 standards. The manufacturer is Biodenta Swiss AG, located in Switzerland. The testing was likely conducted in a lab in Switzerland or another accredited facility.
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. This is a physical medical device. Ground truth in this context refers to established engineering standards (ISO 14801) and regulatory definitions of "substantial equivalence," not expert interpretation of clinical data or images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a physical medical device; there is no "test set" requiring adjudication in the context of reader studies. The evaluation is based on meeting engineering standards and regulatory equivalence.
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. This is a physical medical device, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Standards: For the fatigue testing, the ground truth is defined by the performance requirements outlined in the ISO 14801 standard.
- Regulatory Framework: For substantial equivalence, the ground truth is adherence to the criteria of "intended use, material composition, fundamental scientific technology, principles of operation, and basic design" as compared to legally marketed predicate devices, as assessed by the FDA.
8. The sample size for the training set
- Not Applicable. This is a physical medical device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. This is a physical medical device; there is no "training set."
§ 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.)