Cleared Traditional

K821777 - BEACH MOUTH MIRROR
(FDA 510(k) Clearance)

K821777 · Pacific Dental Corp. · Dental
Jul 1982
Decision
19d
Days
Class 1
Risk

K821777 is an FDA 510(k) clearance for the BEACH MOUTH MIRROR. This device is classified as a Mirror, Mouth (Class I — General Controls, product code EAX).

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 K821777 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 EAX — Mirror, Mouth
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4565