Neoss ProActive Tapered Implant
FDA 510(k)Class II (US FDA 510(k))
by Neoss, Ltd.
Identifiers
- 510(k) Number
- K113376 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 Neoss ProActive Tapered Implant is a dental implant classified under the Dental Implant, Endosseous nomenclature. It is designed for osseointegration within the alveolar bone to support dental prostheses, providing a stable foundation for single-tooth or multi-unit restorations. Its tapered design enhances primary stability during insertion, particularly in bone of varying density. The implant features a threaded surface to promote bone integration and long-term fixation.
This implant is supplied as a sterile, single-use device intended for surgical placement by dental professionals. It is compatible with a range of abutments, scan bodies, and other restorative components, enabling versatile prosthetic solutions. The device is regulated under FDA 510K clearance (K113376) and adheres to dental implant standards for biocompatibility and structural integrity. Storage requires protection from moisture and physical damage, as specified in the manufacturer’s instructions.
Frequently asked questions
What is the Neoss ProActive Tapered Implant used for?
The Neoss ProActive Tapered Implant is designed for osseointegration within the alveolar bone to provide a stable foundation for dental prostheses. Its tapered shape and threaded surface improve primary stability during insertion, making it suitable for both single-tooth and multi-unit restorations in bone of varying density.
How is the Neoss ProActive Tapered Implant supplied and prepared for use?
The implant is supplied as a sterile, single-use device, ensuring it is ready for surgical placement by dental professionals without additional sterilization. This design minimizes contamination risks and adheres to best practices for implant handling.
Is the Neoss ProActive Tapered Implant compatible with other dental components?
Yes, the implant is engineered to work with a variety of dental abutments, scan bodies, and restorative components. This compatibility allows clinicians to customize prosthetic solutions based on patient-specific needs, ensuring versatility in treatment planning.
How should the Neoss ProActive Tapered Implant be stored?
Storage requires protection from moisture and physical damage to maintain sterility and structural integrity. Follow the manufacturer’s instructions closely, as improper storage conditions could compromise the implant’s performance or safety.
What regulatory clearance does the Neoss ProActive Tapered Implant hold?
The implant has received FDA 510K clearance under the classification of Dental Implant, Endosseous, with the clearance number K113376. This designation confirms its compliance with U.S. regulatory standards for dental implants, including biocompatibility and structural integrity.
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: Neoss Home, Neoss ProActive Tapered, Produkte – Neoss DE, Neoss ProActive® Tapered Implant Kit, Neoss ProActive Tapered Dental Implant | SpotImplant
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113376 | Class II | Active |
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Manufacturer
- Manufacturer
- Neoss, Ltd.
Sources (1)
- FDA 510(k) K113376 24 fields · synced Oct 1, 2026