Cleared Traditional

HYGIENIC 5 & 6 RUBBER DAM FRAME

K770117 · Hygienic Dental Mfg., Co., The · Dental
Jan 1977
Decision
7d
Days
Class 1
Risk

About This 510(k) Submission

K770117 is an FDA 510(k) clearance for the HYGIENIC 5 & 6 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 January 28, 1977, 7 days after receiving the submission on January 21, 1977. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K770117 FDA.gov
FDA Decision Cleared SESE
Date Received January 21, 1977
Decision Date January 28, 1977
Days to Decision 7 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