Identifiers
- 510(k) Number
- K925849 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 Zest Implant Anchor is a dental implant device. It is classified under the product code DZE. The device is substantially equivalent and has a traditional clearance type.
The Zest Implant Anchor is supplied by Zest Anchors, Inc. and has received FDA 510K authorization. It is used in dental applications, specifically in overdenture attachment systems. The device has a specific k number, K925849.
Frequently asked questions
What is the Zest Implant Anchor used for?
The Zest Implant Anchor is used in dental applications, specifically in overdenture attachment systems, to provide a secure and stable anchor for dentures.
What type of clearance does the Zest Implant Anchor have?
The Zest Implant Anchor has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.
What is the product code for the Zest Implant Anchor?
The Zest Implant Anchor is classified under the product code DZE, which is a specific code assigned by the FDA for dental implant devices.
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: Dental Implant Manufacturer of Overdenture Attachment Systems | Zest ..., Products > Zest Anchors | Zest Dental Solutions, Our Company — ZestDent.Global, Zest Anchors — ZestDent.Global
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K925849 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, Inc.
Sources (1)
- FDA 510(k) K925849 24 fields · synced Oct 1, 2026