Biodenta Dental Implant System – Bone Level D 3.0 to 6.0 mm
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K123512 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 D 3.0 to 6.0 mm is an endosteal dental implant designed for osseointegrative placement within the mandible or maxilla. It provides a threaded, bone-level interface to support single or multiple tooth restorations, including terminal or intermediate prosthetics, via abutment attachment.
This system is supplied as a sterile, single-use implant intended for surgical use in dental settings. Implants are available in diameters ranging from 3.0 mm to 6.0 mm, with thread designs optimized for stress distribution. Authorized for use under FDA 510(k) clearance (K123512), it adheres to dental implant nomenclature standards and is classified under product code DZE.
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 D 3.0 to 6.0 Mm, Biodenta - Your Total Solution Provider, PDF Product Catalog - Biodenta, Biodenta Dental Implant System-bone Level Tapered D3.0 and L6.5mm ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123512 | Class II | Active |
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Manufacturer
- Manufacturer
- Biodenta Swiss AG
Sources (1)
- FDA 510(k) K123512 24 fields · synced Oct 6, 2026