510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K821824Substantially Equivalent

Tem-Stik

Coralite Dental Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821824 is the FDA 510(k) clearance record for TEM-STIK, a class II device, cleared for Coralite Dental Products, Inc. on under FDA product code EMA (Cement, Dental). FDA records list one 510(k) clearance for Coralite Dental Products, Inc. As of , FDA records show no recalls naming K821824.

Clearance record

Decision date
Received
(14 days to decision)
Product code
EMA Cement, Dental
Regulation
21 CFR 872.3275
Device class
Class II
Review panel
Dental
Applicant
Coralite Dental Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EMA

Trailing 12 months
10 clearances under product code EMA in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code EMA, trailing twelve months
MonthClearances
November 20250
December 20253
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20262
September 20261
October 20260