Biodenta Dental Implant System – Bone Level Tapered
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123415 FDA 510(k)
- FDA Product Code
- DZE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3640 FDA 510(k)
- Regulation Number
- 872.3640 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biodenta Dental Implant System – Bone Level Tapered is a dental implant designed for osseointegration within the mandible or maxilla. It is classified as a Dental Implant (DZE) and features a bone-level tapered design intended to support single or multiple tooth restorations, intermediate abutments, or overdenture retention.
This system is supplied sterile and intended for single-use, with regulatory authorisations including FDA 510(k) clearance and MDD compliance. It is distributed by Biodenta Swiss AG, based in Berneck, Switzerland, and is intended for surgical placement by trained dental professionals. No MRI safety information or reusable specifications are provided in the data.
Frequently asked questions
What types of dental restorations can the Biodenta Dental Implant System – Bone Level Tapered support?
The Biodenta Dental Implant System – Bone Level Tapered is designed to support single or multiple tooth restorations, intermediate abutments, or overdenture retention in either the mandible or maxilla. Its bone-level tapered design is optimized for osseointegration, allowing for stable integration with dental prosthetics.
Is the Biodenta Dental Implant System – Bone Level Tapered intended for reuse, or is it single-use?
The Biodenta Dental Implant System – Bone Level Tapered is explicitly intended for single-use only. It is supplied sterile to ensure safety and reliability for one surgical procedure, preventing cross-contamination risks.
How is the Biodenta Dental Implant System – Bone Level Tapered regulated, and what does that mean for clinicians?
The system holds FDA 510(k) clearance under the classification of a Dental Implant (DZE) and complies with the MDD (Medical Device Directive). This means it has undergone regulatory review to confirm its safety and effectiveness for osseointegration in the mandible or maxilla, ensuring it meets established standards for dental implants.
Who is responsible for placing the Biodenta Dental Implant System – Bone Level Tapered, and where is it manufactured?
The system is intended for surgical placement only by trained dental professionals. It is manufactured by Biodenta Swiss AG, based in Berneck, Switzerland, and distributed from their facility at Tramstrasse 16, 9442 Berneck, St.Gallen.
Does the Biodenta Dental Implant System – Bone Level Tapered require any special handling or storage instructions?
Since the system is supplied sterile and for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. The sterile packaging must remain intact until immediate use to maintain its integrity and prevent contamination.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Biodenta Dental Implant System- Bone Level Tapered, Biodenta Dental Implants | SpotImplant, Implants - Biodenta - Your Total Solution Provider
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K123415 | Class II | Active |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
Sources (2)
- FDA 510(k) K123415 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026