Cleared Traditional

HYGIENIC RUBBER DAM FRAME

K780746 · Hygienic Dental Mfg., Co., The · Dental
May 1978
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K780746 is an FDA 510(k) clearance for the HYGIENIC RUBBER DAM FRAME, a Frame, Rubber Dam (Class I — General Controls, product code EJE), submitted by Hygienic Dental Mfg., Co., The (Mchenry, US). The FDA issued a Cleared decision on May 12, 1978, 29 days after receiving the submission on April 13, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K780746 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1978
Decision Date May 12, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EJE — Frame, Rubber Dam
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300