Cleared Traditional

ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL)

K934668 · Zest Anchors, Inc. · Dental
Jun 1994
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K934668 is an FDA 510(k) clearance for the ZEST IMPLANT ANCHOR ADVANCED GENERATION (DENTAL), a Implant, Endosseous, Root-form (Class II — Special Controls, product code DZE), submitted by Zest Anchors, Inc. (Escondido, US). The FDA issued a Cleared decision on June 22, 1994, 266 days after receiving the submission on September 29, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K934668 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 1993
Decision Date June 22, 1994
Days to Decision 266 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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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