510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K053014Substantially Equivalent

Poly Siloxane Impression Material

Den-Mat Holdings, LLC, London, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053014 is the FDA 510(k) clearance record for POLY SILOXANE IMPRESSION MATERIAL, a class II device, cleared for Clinician'S Choice Dental Products, Inc. on under FDA product code ELW (Material, Impression). FDA records list 10 510(k) clearances for DEN-MAT HOLDINGS, LLC, from to . As of , FDA records show one recall naming K053014.

Clearance record

Decision date
Received
(20 days to decision)
Product code
ELW Material, Impression
Regulation
21 CFR 872.3660
Device class
Class II
Review panel
Dental
Applicant
Clinician'S Choice Dental Products, Inc. 1980 Hyde Park Rd., London, Ontario, CA
510(k) summary
Statement
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