Cleared Traditional

K821779 - BEACH AMALGAM CARRIER, GUN TYPE
(FDA 510(k) Clearance)

K821779 · Pacific Dental Corp. · Dental

Jul 1982

Decision

19d

Days

Class 1

Risk

K821779 is an FDA 510(k) clearance for the BEACH AMALGAM CARRIER, GUN TYPE. This device is classified as a Burnisher, Operative (Class I — General Controls, product code EKJ).

Submitted by Pacific Dental Corp. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1982, 19 days after receiving the submission on June 17, 1982.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K821779 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 1982
Decision Date	July 06, 1982
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—