Cleared Traditional

ZEST IMPLANT ANCHOR

K925849 · Zest Anchors, Inc. · Dental
Nov 1994
Decision
730d
Days
Class 2
Risk

About This 510(k) Submission

K925849 is an FDA 510(k) clearance for the ZEST IMPLANT ANCHOR, a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Zest Anchors, Inc. (Washington, US). The FDA issued a Cleared decision on November 18, 1994, 730 days after receiving the submission on November 18, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K925849 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1992
Decision Date November 18, 1994
Days to Decision 730 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

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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