Cleared Traditional

K874294 - AUTOCHUCK ATTACHMENT
(FDA 510(k) Clearance)

Dec 1987
Decision
70d
Days
Class 1
Risk

K874294 is an FDA 510(k) clearance for the AUTOCHUCK ATTACHMENT. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by Den-Tal-Ez Mfg Co., Inc. (Valley Forge, US). The FDA issued a Cleared decision on December 29, 1987, 70 days after receiving the submission on October 20, 1987.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K874294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 29, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4200

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