510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210027Unknown

The Cooral System

Braincool AB, Lund, SE / Direct, Unknown
FDA source (opens on fda.gov)

DEN210027 is the FDA 510(k) clearance record for The Cooral System, a class II device, cleared for Braincool AB on under FDA product code QUA (Intraoral Cooling Device). FDA's definition for product code QUA reads: "An intraoral cooling device is a prescription use device that is intended to cool the mouth for patients at risk for oral mucositis. An intraoral cooling device consists of a removable mouthpiece and accessories that cool oral mucosal...". FDA records list 4 510(k) clearances for Braincool AB, from to . As of , FDA records show no recalls naming DEN210027.

Clearance record

Decision date
Received
(469 days to decision)
Product code
QUA Intraoral Cooling Device
Regulation
21 CFR 872.5590
Device class
Class II
Review panel
Dental
Applicant
Braincool AB Scheelevägen 2, Medicon Village, Lund, SE
Third party review
No

Clearances, product code QUA

Trailing 12 months

FDA records hold no clearances under product code QUA in the trailing twelve months.

FDA records show no clearances under product code QUA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QUA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260