Cleared Traditional

PERMAGEN UNIVERSAL BONDING RESIN (K933745) - FDA 510(k) Clearance

Class I Dental device.

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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (EBH) and FDA review panel - the closest regulatory comparables to K933745.
LC TRAY MATERIAL
K923979 · Dentsply Intl. · Nov 1992
IMPRESSION TRAY
K872210 · Dentsply Intl. · Jun 1987
RESIN TRAY IMPRESSION MATERIAL
K854042 · Dentsply Intl. · Nov 1985
VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE
K844471 · Dentsply Intl. · Feb 1985
HYBRID DENTAL PRODUCT
K813550 · Dentsply Intl. · Feb 1982
P-10 POSTERIOR FILLING MATERIAL
K802751 · 3M Company · Nov 1980