Cleared Traditional

K790601 - DENTAL HANDPIECE
(FDA 510(k) Clearance)

May 1979
Decision
66d
Days
Class 1
Risk

K790601 is an FDA 510(k) clearance for the DENTAL HANDPIECE. This device is classified as a Handpiece, Air-powered, Dental (Class I - General Controls, product code EFB).

Submitted by Venture Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1979, 66 days after receiving the submission on March 26, 1979.

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

Submission Details

510(k) Number K790601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1979
Decision Date May 31, 1979
Days to Decision 66 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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