Zest Implant Anchor Advanced Generation (Dental)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K934668 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)
This device is a dental implant anchor designed for use in dental applications. It is intended to provide anchorage for dental prosthetics.
The device is supplied non-sterile and is intended for reusable use. It is manufactured by Zest Anchors, Inc. and received FDA 510(k) clearance under K934668 on June 22, 1994, with a substantially equivalent determination. The product code is DZE and it is classified under the Dental advisory committee.
Frequently asked questions
What is the Zest Implant Anchor Advanced Generation used for?
This device is a dental implant anchor intended to provide anchorage for dental prosthetics in dental applications, as stated in its description.
Is the Zest Implant Anchor Advanced Generation sterile or non-sterile, and is it single-use or reusable?
The device is supplied non-sterile and is intended for reusable use, meaning it can be cleaned and reused after appropriate reprocessing, as specified in the device data.
What regulatory pathway was used for the Zest Implant Anchor Advanced Generation, and what is its K number?
The device received FDA 510(k) clearance under K934668 on June 22, 1994, with a substantially equivalent determination, which is the regulatory route it followed for market authorization.
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: Zest Locator Online Shop: Deutschland, Österreich, Schweiz, Dental Implant Manufacturer of Overdenture Attachment Systems | Zest ..., Zest Dental Solutions | ADSystems, Implants | Product Catalog | Zest Dental Solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K934668 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, Inc.
Sources (1)
- FDA 510(k) K934668 24 fields · synced Sep 23, 2026