Cleared Traditional

K902743 - DEGUFILL (TM) ETCHANT GEL

K902743 is the FDA 510(k) clearance for DEGUFILL (TM) ETCHANT GEL by Degussa AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K902743 · Degussa AG · Dental device
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Aug 1990
Decision
40d
Days
Class 2
Risk

K902743 is an FDA 510(k) clearance for the DEGUFILL (TM) ETCHANT GEL. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Degussa AG (South Plainfield, US). The FDA issued a Cleared decision on August 1, 1990 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Degussa AG devices

Submission Details

510(k) Number K902743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1990
Decision Date August 01, 1990
Days to Decision 40 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
87d faster than avg
Panel avg: 127d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 584
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K902743.
DEGUFILL (TM)
K902745 · Degussa AG · Aug 1990
PERTAC-HYBRID
K900510 · Espe GmbH (Us) · Aug 1990
DEGUFILL (R) ETCHANT
K901872 · Degussa AG · Aug 1990
HELIO PROGRESS (DENTAL COMPOSITE)
K901914 · Ivoclar North America, Inc. · Jun 1990
DUAL CEMENT
K901917 · Ivoclar North America, Inc. · Jun 1990
HELIO LINK (RESIN CEMENT)
K901910 · Ivoclar North America, Inc. · Jun 1990