Cleared Traditional

PROPHYLAXIS CUPS AND POLISHERS

K790723 · Young Dental Manufacturing Co. 1, LLC · Dental
Jun 1979
Decision
66d
Days
Class 1
Risk

About This 510(k) Submission

K790723 is an FDA 510(k) clearance for the PROPHYLAXIS CUPS AND POLISHERS, a Cup, Prophylaxis (Class I — General Controls, product code EHK), 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 872.6290.

Submission Details

510(k) Number K790723 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 EHK — Cup, Prophylaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6290