Cleared Traditional

PASTE, PRO CARE PROPHYLAXIS

K782104 · Young Dental Manufacturing Co. 1, LLC · General & Plastic Surgery
Jan 1979
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K782104 is an FDA 510(k) clearance for the PASTE, PRO CARE PROPHYLAXIS, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), submitted by Young Dental Manufacturing Co. 1, LLC (Walker, US). The FDA issued a Cleared decision on January 3, 1979, 15 days after receiving the submission on December 19, 1978. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number K782104 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 1978
Decision Date January 03, 1979
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZE — Prosthesis, Nose, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3680

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