510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994144Substantially Equivalent

Toothbrush Wash

Cal Huech, Inc., Warner Robins GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994144 is the FDA 510(k) clearance record for TOOTHBRUSH WASH, a class I device, cleared for Cal Huech, Inc. on under FDA product code EFW (Toothbrush, Manual). FDA records list one 510(k) clearance for Cal Huech, Inc. As of , FDA records show no recalls naming K994144.

Clearance record

Decision date
Received
(86 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Cal Huech, Inc. 105 Settlers Trl., Warner Robins GA
510(k) summary
Statement
Third party review
No

Clearances, product code EFW

Trailing 12 months

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

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