Cleared Traditional

K873002 - MIN-IDENTOFLEX (FDA 510(k) Clearance)

Aug 1987
Decision
13d
Days
Class 1
Risk

K873002 is an FDA 510(k) clearance for the MIN-IDENTOFLEX. This device is classified as a Disk, Abrasive (Class I - General Controls, product code EHJ).

Submitted by Centrix, Inc. (Milford, US). The FDA issued a Cleared decision on August 17, 1987, 13 days after receiving the submission on August 4, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6010.

Submission Details

510(k) Number K873002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1987
Decision Date August 17, 1987
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EHJ — Disk, Abrasive
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.6010