Cleared Traditional

K896539 - PERMADYNE GARANT LOW VISCOSITY

K896539 is the FDA 510(k) clearance for PERMADYNE GARANT LOW VISCOSITY by Espe GmbH (Us). It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K896539 · Espe GmbH (Us) · Dental device
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Feb 1990
Decision
86d
Days
Class 2
Risk

K896539 is an FDA 510(k) clearance for the PERMADYNE GARANT LOW VISCOSITY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Espe GmbH (Us) (Lake Worth, US). The FDA issued a Cleared decision on February 9, 1990 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Espe GmbH (Us) devices

Submission Details

510(k) Number K896539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1989
Decision Date February 09, 1990
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 167
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K896539.
DEGUFLEX (R) CS PUTTY
K901867 · Degussa AG · Sep 1990
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · Kulzer, Inc. · Jun 1990
EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL
K896468 · Ivoclar North America, Inc. · Apr 1990
POLYETHER-RETARDER
K892412 · Espe GmbH (Us) · Dec 1989
PALGARAPID
K892839 · Espe GmbH (Us) · Oct 1989
RESOUND IMPRESSION MATERIAL
K892935 · Resound Corp. · Jul 1989