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
K041098Substantially Equivalent

Cool Temp Natural

Coltene, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K041098 is the FDA 510(k) clearance record for COOL TEMP NATURAL, a class II device, cleared for Coltene AG on under FDA product code EBG (Crown And Bridge, Temporary, Resin). FDA records list 15 510(k) clearances for Coltene AG, from to . As of , FDA records show no recalls naming K041098.

Clearance record

Decision date
Received
(16 days to decision)
Product code
EBG Crown And Bridge, Temporary, Resin
Regulation
21 CFR 872.3770
Device class
Class II
Review panel
Dental
Applicant
Coltene AG 1349 Lexington Ave., New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code EBG

Trailing 12 months
2 clearances under product code EBG in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code EBG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260