510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011666Substantially Equivalent

Chillit

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

K011666 is the FDA 510(k) clearance record for CHILLIT, a class II device, cleared for Heatshield, Inc. on under FDA product code EAT (Tester, Pulp). FDA records list one 510(k) clearance for Heatshield, Inc. As of , FDA records show no recalls naming K011666.

Clearance record

Decision date
Received
(68 days to decision)
Product code
EAT Tester, Pulp
Regulation
21 CFR 872.1720
Device class
Class II
Review panel
Dental
Applicant
Heatshield, Inc. 110 Lockwood Ave., New Rochelle NY
510(k) summary
Statement
Third party review
No

Clearances, product code EAT

Trailing 12 months

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

FDA records show no clearances under product code EAT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAT, 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