Cleared Traditional

LOCATOR IMPLANT ANCHOR

K994257 · Zest Anchors, Inc. · Dental
Mar 2000
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K994257 is an FDA 510(k) clearance for the LOCATOR IMPLANT ANCHOR, 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 March 17, 2000, 92 days after receiving the submission on December 16, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3640.

Submission Details

510(k) Number K994257 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1999
Decision Date March 17, 2000
Days to Decision 92 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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