Cleared Traditional

WEDJETS

K900844 · The Hygenic Corp. · Dental
Apr 1990
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K900844 is an FDA 510(k) clearance for the WEDJETS, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on April 16, 1990, 53 days after receiving the submission on February 22, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K900844 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 1990
Decision Date April 16, 1990
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

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