Nanotite Prevail, Certain, Parellel Walled, Tapered, External Hex
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K072363 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 Nanotite Prevail, Certain, Parallel-Walled, Tapered, External Hex Dental Implant is an endosseous dental implant designed for osseointegration in the jawbone. It features a proprietary NanoTite surface treatment, combining an acid-etched titanium base with calcium phosphate discrete crystalline deposition (DCD) to enhance bone integration. The implant’s external hex connection and tapered design provide stability for prosthetic restorations, while its parallel-walled body ensures precise placement. Constructed from commercially pure titanium, it is engineered to support single-tooth restorations in dental applications.
This implant is supplied in four diameters and five lengths, allowing customisation for varying anatomical requirements. It is intended for surgical placement by dental professionals and is not pre-sterilised for single-use; sterilisation and handling must comply with dental implant protocols. The device holds FDA 510(k) clearance (K072363) under the Dental (DE) advisory committee, classified as substantially equivalent to predicate devices. Storage and handling should follow standard aseptic techniques for metallic implants, and compatibility is confirmed with compatible abutment systems.
Frequently asked questions
What is the Nanotite Prevail Parallel-Walled Tapered Implant designed for?
This implant is designed for osseointegration in the jawbone to support single-tooth restorations. Its proprietary NanoTite surface—combining an acid-etched titanium base with calcium phosphate discrete crystalline deposition—promotes stronger bone integration compared to standard implants. The tapered design and external hex connection ensure stability for prosthetic attachments, making it ideal for precise, long-term dental reconstruction.
How is the Nanotite Prevail implant supplied, and is it pre-sterilized?
The implant is supplied in four diameters and five lengths to accommodate varying anatomical needs. It is not pre-sterilized for single-use; instead, it must be sterilized and handled according to standard dental implant protocols to maintain aseptic conditions. This ensures compatibility with surgical environments and reduces contamination risks during placement.
Is the Nanotite Prevail implant reusable, or is it intended for single-use?
The implant is not designed for single-use. While it is constructed from commercially pure titanium—a durable material—its reuse would require strict adherence to sterilization and handling guidelines. However, dental professionals should follow manufacturer-recommended protocols to ensure safety and efficacy, as repeated sterilization cycles may affect long-term performance.
What regulatory clearance does the Nanotite Prevail implant hold?
The implant holds FDA 510(k) clearance (K072363) under the Dental (DE) advisory committee, classified as substantially equivalent to predicate devices. This clearance confirms its compliance with U.S. safety and performance standards for dental implants, ensuring it meets regulatory requirements for clinical use in the U.S. market.
How should the Nanotite Prevail implant be stored, and what compatibility does it have with abutments?
Storage must follow standard aseptic techniques for metallic implants to prevent contamination. The implant is engineered to be compatible with compatible abutment systems, ensuring secure and stable prosthetic connections. Always verify compatibility with the specific abutment brand and model to avoid fit or stability issues during restoration.
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: Biomet 3i Tapered (Ext) Dental Implant | SpotImplant - None, Nanotite Prevail,Certain,Parellel Walled,Tapered,External Hex, Biomet 3i Tapered Certain PREVAIL Dental Implant | SpotImplant - None
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072363 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet 3i, Inc.
Sources (1)
- FDA 510(k) K072363 24 fields · synced Oct 1, 2026