Identifiers
- 510(k) Number
- K101977 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 Tapered Screw-Vent T Implant is a dental implant device designed for use in dental procedures. It features a tapered body with V-shaped threads and an internal hexagon connection with bevel, providing primary stability for implant placement.
This implant is supplied in various sizes and is intended for single-use applications. It is manufactured by Zimmer Dental Inc. and has received FDA 510(k) clearance as substantially equivalent under product code DZE. The device is not MRI compatible and should be stored according to manufacturer instructions.
Frequently asked questions
What is the Tapered Screw-Vent T Implant used for?
The Tapered Screw-Vent T Implant is a dental implant device designed for use in dental procedures. It features a tapered body with V-shaped threads and an internal hexagon connection with bevel, providing primary stability for implant placement.
Is the Tapered Screw-Vent T Implant single-use or reusable?
The Tapered Screw-Vent T Implant is intended for single-use applications. It should not be reused on multiple patients as this could compromise sterility and device performance.
What sizes are available for the Tapered Screw-Vent T Implant?
The Tapered Screw-Vent T Implant is supplied in various sizes to accommodate different clinical needs. Specific size options should be referenced in the product catalog or with the manufacturer directly.
How should the Tapered Screw-Vent T Implant be stored?
The Tapered Screw-Vent T Implant should be stored according to manufacturer instructions. It is not MRI compatible, so storage should be in a location away from MRI equipment as specified by Zimmer Dental Inc.
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: Tapered Screw-Vent® Implant | ZimVie Americas, PDF Tapered Screw-Vent Implant System - preferreddentallab.com, Zimmer-Biomet Tapered Screw-Vent (TSV) 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 | K101977 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Dental Inc.
- FDA Applicant
- Zimmer Dental, Inc.
Sources (1)
- FDA 510(k) K101977 24 fields · synced Oct 6, 2026