Cleared Traditional

K896786 - ZONAREX FINAL IMPRESSION COMPOUND

K896786 is an FDA 510(k) clearance for ZONAREX FINAL IMPRESSION COMPOUND, manufactured by Craft Dental Laboratory, Inc.. 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.

K896786 · Craft Dental Laboratory, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
136d
Days
Class 2
Risk

K896786 is an FDA 510(k) clearance for the ZONAREX FINAL IMPRESSION COMPOUND. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Craft Dental Laboratory, Inc. (Milwaukee, US). The FDA issued a Cleared decision on April 19, 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 Craft Dental Laboratory, Inc. devices

FDA 510(k) Submission Details - K896786

510(k) Number K896786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date April 19, 1990
Days to Decision 136 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
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 330
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K896786.
DEGUFLEX (R) CS PUTTY
K901867 · 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
FIRST IMPRESSION TM
K894282 · Coe Laboratories, Inc. · Dec 1989
POLYETHER-RETARDER
K892412 · Espe GmbH (Us) · Dec 1989