Cleared Traditional

PERMAGEN UNIVERSAL BONDING RESIN

K933745 · Bio-Systems Research · Dental
Jan 1994
Decision
176d
Days
Class 1
Risk

About This 510(k) Submission

K933745 is an FDA 510(k) clearance for the PERMAGEN UNIVERSAL BONDING RESIN, a Material, Impression Tray, Resin (Class I — General Controls, product code EBH), submitted by Bio-Systems Research (Lake Oswego, US). The FDA issued a Cleared decision on January 26, 1994, 176 days after receiving the submission on August 3, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.3670.

Submission Details

510(k) Number K933745 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1993
Decision Date January 26, 1994
Days to Decision 176 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBH — Material, Impression Tray, Resin
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3670