Cleared Traditional

K901872 - DEGUFILL ETCHANT

K901872 is the FDA 510(k) clearance for DEGUFILL ETCHANT by Degussa AG. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K901872 · Degussa AG · Dental device
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Aug 1990
Decision
99d
Days
Class 2
Risk

K901872 is an FDA 510(k) clearance for the DEGUFILL (R) ETCHANT. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on August 1, 1990 after a review of 99 days - within the typical 510(k) review window.

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: 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 Degussa AG devices

Submission Details

510(k) Number K901872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date August 01, 1990
Days to Decision 99 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
28d faster than avg
Panel avg: 127d · This submission: 99d
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 K901872.
DEGUFILL (R) H
K901869 · Degussa AG · Aug 1990
DEGUFILL (TM)
K902745 · Degussa AG · Aug 1990
PERTAC-HYBRID
K900510 · Espe GmbH (Us) · Aug 1990
DEGUFILL (TM) ETCHANT GEL
K902743 · Degussa AG · Aug 1990
HELIO PROGRESS (DENTAL COMPOSITE)
K901914 · Ivoclar North America, Inc. · Jun 1990
DUAL CEMENT
K901917 · Ivoclar North America, Inc. · Jun 1990