Cleared Traditional

K760956 - SURGICAL MICRO DRILL
(FDA 510(k) Clearance)

Nov 1976
Decision
18d
Days
Class 1
Risk

K760956 is an FDA 510(k) clearance for the SURGICAL MICRO DRILL. This device is classified as a Drill, Dental, Intraoral (Class I - General Controls, product code DZA).

Submitted by American Safety Equipment Corp. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1976, 18 days after receiving the submission on November 1, 1976.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number K760956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1976
Decision Date November 19, 1976
Days to Decision 18 days
Submission Type Traditional
Review Panel Dental (DE)
Summary

Device Classification

Product Code DZA — Drill, Dental, Intraoral
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.4130

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