Cleared Traditional

ZEST MARK II (STANDARD & MINI)

K861561 · Zest Anchors, Inc. · Dental
May 1986
Decision
26d
Days
Class 1
Risk

About This 510(k) Submission

K861561 is an FDA 510(k) clearance for the ZEST MARK II (STANDARD & MINI), a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Zest Anchors, Inc. (San Diego, US). The FDA issued a Cleared decision on May 21, 1986, 26 days after receiving the submission on April 25, 1986. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number K861561 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1986
Decision Date May 21, 1986
Days to Decision 26 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EGG — Attachment, Precision, All
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3165

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