Cleared Traditional

PROPHYLAXIS ANGLE

K790722 · Young Dental Manufacturing Co. 1, LLC · Dental
Jun 1979
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K790722 is an FDA 510(k) clearance for the PROPHYLAXIS ANGLE, a Handpiece, Contra- And Right-angle Attachment, Dental (Class I — General Controls, product code EGS), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 15, 1979, 66 days after receiving the submission on April 10, 1979. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K790722 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 1979
Decision Date June 15, 1979
Days to Decision 66 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EGS — Handpiece, Contra- And Right-angle Attachment, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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