Cleared Traditional

K901867 - DEGUFLEX CS PUTTY

K901867 is the FDA 510(k) clearance for DEGUFLEX CS PUTTY by Degussa AG. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K901867 · Degussa AG · Dental device
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Sep 1990
Decision
135d
Days
Class 2
Risk

K901867 is an FDA 510(k) clearance for the DEGUFLEX (R) CS PUTTY. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Degussa AG (West Germany, DE). The FDA issued a Cleared decision on September 6, 1990 after a review of 135 days - within the typical 510(k) review window.

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: 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 K901867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date September 06, 1990
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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 K901867.
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990
DEGUFLEX (R) CS LIGHT
K901866 · Degussa AG · Sep 1990
DEGUFLEX MONOPHASE
K901865 · 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
PERMADYNE GARANT LOW VISCOSITY
K896539 · Espe GmbH (Us) · Feb 1990