Cleared Traditional

RUBBER DAM HOLDER

K781520 · Young Dental Manufacturing Co. 1, LLC · Dental
Oct 1978
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K781520 is an FDA 510(k) clearance for the RUBBER DAM HOLDER, a Frame, Rubber Dam (Class I — General Controls, product code EJE), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978, 39 days after receiving the submission on September 1, 1978. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K781520 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1978
Decision Date October 10, 1978
Days to Decision 39 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