Cleared Traditional

K901866 - DEGUFLEX (R) CS LIGHT

K901866 is an FDA 510(k) clearance for DEGUFLEX CS LIGHT, manufactured by Degussa AG. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K901866

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.

ELW Device Classification - Class 2, Special Controls

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 321
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K901866.
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990
ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS
K903292 · Coe Laboratories, Inc. · Oct 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