Cleared Traditional

K770997 - PRO-CARE
(FDA 510(k) Clearance)

K770997 · Young Dental Manufacturing Co. 1, LLC · Dental

Jun 1977

Decision

19d

Days

Class 1

Risk

K770997 is an FDA 510(k) clearance for the PRO-CARE, a Toothbrush, Powered (Class I — General Controls, product code JEQ), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 20, 1977, 19 days after receiving the submission on June 1, 1977. This device falls under the Dental review panel. Regulated under 21 CFR 872.6865.

Submission Details

510(k) Number	K770997 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 1977
Decision Date	June 20, 1977
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—