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Bioceram Zest Plant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K840244

by Zest Anchors, Inc.

Identifiers

510(k) Number
K840244 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 Bioceram Zest Plant is a dental implant attachment system classified under the product code DZE. It is designed as a removable dental attachment used for securing prosthetic devices in patients with partial or full edentulism, providing stability and retention for removable dental restorations.

This device is intended for use in dental settings and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of May 1, 1984. The Bioceram Zest Plant is supplied as a reusable component and is regulated under the Dental advisory committee. No additional sterility or MRI safety information is provided in the available data.

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: BIOCERAM ZEST PLANT (K840244) — FDA 510 (k) | Innolitics, BIOCERAM ZEST PLANT 510 (k) K840244 - FDA.report, Products > Zest Anchors | Zest Dental Solutions, ZEST PLANT (K801524) — FDA 510(k) | Innolitics, Zest Anchors, Inc. FDA 510 (k) Products (1980-2015)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zest Anchors, Inc.

Sources (1)

  • FDA 510(k) K840244 24 fields · synced Sep 19, 2026