Cleared Traditional

GENERAL PURPOSE DENTAL TRAY

K962527 · Medcare Medical Group, Inc. · Dental
Aug 1996
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K962527 is an FDA 510(k) clearance for the GENERAL PURPOSE DENTAL TRAY, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Medcare Medical Group, Inc. (East Swanzey, US). The FDA issued a Cleared decision on August 1, 1996, 35 days after receiving the submission on June 27, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K962527 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1996
Decision Date August 01, 1996
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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