Cleared Traditional

SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS

K073478 · Sybron Dental Specialties, Inc. · Dental
Sep 2008
Decision
267d
Days
Class 1
Risk

About This 510(k) Submission

K073478 is an FDA 510(k) clearance for the SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on September 3, 2008, 267 days after receiving the submission on December 11, 2007. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K073478 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 2007
Decision Date September 03, 2008
Days to Decision 267 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

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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