Identifiers
- 510(k) Number
- K801524 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 Plant is a dental implant attachment system classified under 21 CFR 872.3640 as an overdenture attachment. It serves as a mechanical connector designed to secure removable dental prostheses to dental implants, providing stability for patients with partial or full edentulism. This device facilitates retention and support for overdentures, improving functionality and comfort in implant-supported restorations.
The Zest Plant is supplied as a reusable component intended for use in dental clinical settings. It is not sterilized for single-use and requires proper cleaning and maintenance per manufacturer guidelines. The device holds an FDA 510(k) clearance (K801524) under the Dental (DZE) product code, with a Substantially Equivalent determination by the Dental (DE) Advisory Committee. No MRI safety or size-specific storage instructions are documented in the regulatory submission.
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: Products > Zest Anchors | Zest Dental Solutions, Dental Implant Manufacturer of Overdenture Attachment Systems | Zest ..., ZEST PLANT (K801524) — FDA 510(k) | Innolitics, ZEST PLANT 510 (k) K801524 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K801524 | Class II | Active |
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Manufacturer
- Manufacturer
- Zest Anchors, Inc.
Sources (1)
- FDA 510(k) K801524 24 fields · synced Sep 19, 2026