510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896785Substantially Equivalent

Zonarex Final Impression Compound, Operatory Heat/

Craft Dental Laboratory, Inc., Milwaukee WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896785 is the FDA 510(k) clearance record for ZONAREX FINAL IMPRESSION COMPOUND, OPERATORY HEAT/, a class II device, cleared for Craft Dental Laboratory, Inc. on under FDA product code ELW (Material, Impression). FDA records list 2 510(k) clearances for Craft Dental Laboratory, Inc. As of , FDA records show no recalls naming K896785.

Clearance record

Decision date
Received
(136 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Craft Dental Laboratory, Inc. 1583 W. Forest Home Ave., Milwaukee WI
Third party review
No

Clearances, product code ELW

Trailing 12 months
3 clearances under product code ELW in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code ELW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20262
October 20260