Cleared Traditional

K933745 - PERMAGEN UNIVERSAL BONDING RESIN

K933745 is an FDA 510(k) clearance for PERMAGEN UNIVERSAL BONDING RESIN, manufactured by Bio-Systems Research. The device is a Class 1 Dental device with product code EBH cleared through the Traditional 510(k) pathway after a 176-day FDA review.

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

K933745 is an FDA 510(k) clearance for the PERMAGEN UNIVERSAL BONDING RESIN. Classified as Material, Impression Tray, Resin (product code EBH), Class I - General Controls.

Submitted by Bio-Systems Research (Lake Oswego, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3670 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Bio-Systems Research devices

FDA 510(k) Submission Details - K933745

510(k) Number K933745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence.

EBH Device Classification - Class 1, General Controls

Product Code EBH Material, Impression Tray, Resin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3670
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EBH Material, Impression Tray, Resin

All 14
Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K933745.
PALATRAY LC MINT
K930487 · Heraeus Kulzer, Inc. · Jun 1993
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 1992
PALADISC LC
K923549 · Heraeus Kulzer, Inc. · Sep 1992
PALAVIT L
K905058 · Kulzer, Inc. · Jun 1991
PALATRAY LC RESIN IMPRESSION TRAY MATERIAL
K902350 · Kulzer, Inc. · Jul 1990
MODIFIED PERMAGUM ADHESIVE
K881838 · Espe GmbH (Us) · Jul 1988