Cleared Traditional

ZEST ENDODONTIC STABILIZER

K801525 · Zest Anchors, Inc. · Dental
Jul 1980
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K801525 is an FDA 510(k) clearance for the ZEST ENDODONTIC STABILIZER, a Splint, Endodontic Stabilizing (Class II — Special Controls, product code ELS), submitted by Zest Anchors, Inc. (Mchenry, 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 review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number K801525 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 ELS — Splint, Endodontic Stabilizing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3890