Cleared Traditional

SPATULA, DENTAL, CEMENT

K871818 · Military Engineering, Inc. · Dental
Jul 1987
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K871818 is an FDA 510(k) clearance for the SPATULA, DENTAL, CEMENT, a Handle, Instrument, Dental (Class I — General Controls, product code EJB), submitted by Military Engineering, Inc. (Plymouth, US). The FDA issued a Cleared decision on July 2, 1987, 52 days after receiving the submission on May 11, 1987. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number K871818 FDA.gov
FDA Decision Cleared SESE
Date Received May 11, 1987
Decision Date July 02, 1987
Days to Decision 52 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJB — Handle, Instrument, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565