Cleared Traditional

K801524 - ZEST PLANT
(FDA 510(k) Clearance)

K801524 · Zest Anchors, Inc. · Dental
Jul 1980
Decision
20d
Days
Class 2
Risk

K801524 is an FDA 510(k) clearance for the ZEST PLANT. This device is classified as a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE).

Submitted by Zest Anchors, Inc. (Walker, US). The FDA issued a Cleared decision on July 21, 1980, 20 days after receiving the submission on July 1, 1980.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K801524 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 1980
Decision Date July 21, 1980
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code DZE — Implant, Endosseous, Root-form
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3640

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