Cleared Traditional

K821780 - BEACH EXPLORER NO. 23T.G.
(FDA 510(k) Clearance)

K821780 · Pacific Dental Corp. · Dental
Jul 1982
Decision
19d
Days
Class 1
Risk

K821780 is an FDA 510(k) clearance for the BEACH EXPLORER NO. 23T.G.. This device is classified as a Explorer, Operative (Class I — General Controls, product code EKB).

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 K821780 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 —

Device Classification

Product Code EKB — Explorer, Operative
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565