Cleared Traditional

K901866 - DEGUFLEX CS LIGHT

K901866 is the FDA 510(k) clearance for DEGUFLEX CS LIGHT by Degussa AG. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K901866 · Degussa AG · Dental device
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Sep 1990
Decision
136d
Days
Class 2
Risk

K901866 is an FDA 510(k) clearance for the DEGUFLEX (R) CS LIGHT. 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 7, 1990 after a review of 136 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 K901866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date September 07, 1990
Days to Decision 136 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
9d slower than avg
Panel avg: 127d · This submission: 136d
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 K901866.
PERFOURM PUTTY SOFT
K910189 · Heraeus Kulzer, Inc. · Jun 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990
DEGUFLEX MONOPHASE
K901865 · Degussa AG · Sep 1990
DEGUFLEX (R) CS PUTTY
K901867 · Degussa AG · Sep 1990
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · Kulzer, Inc. · Jun 1990