Cleared Traditional

K901681 - FORMASILA POLYVINYL SILOXANE LINE

K901681 is the FDA 510(k) clearance for FORMASILA POLYVINYL SILOXANE LINE by Kulzer, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K901681 · Kulzer, Inc. · Dental device
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Jun 1990
Decision
65d
Days
Class 2
Risk

K901681 is an FDA 510(k) clearance for the FORMASIL(R)A POLYVINYL SILOXANE LINE. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kulzer, Inc. (Chicago, US). The FDA issued a Cleared decision on June 15, 1990 after a review of 65 days - a notably fast clearance cycle.

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: 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 Kulzer, Inc. devices

Submission Details

510(k) Number K901681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1990
Decision Date June 15, 1990
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K901681.
DEGUFLEX (R) CS LIGHT
K901866 · Degussa AG · Sep 1990
DEGUFLEX MONOPHASE
K901865 · Degussa AG · Sep 1990
DEGUFLEX (R) CS PUTTY
K901867 · Degussa AG · Sep 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
POLYETHER-RETARDER
K892412 · Espe GmbH (Us) · Dec 1989