510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K852400Substantially Equivalent

Plak Smacker

Plak Smacker Toothbrush Co., Corna CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852400 is the FDA 510(k) clearance record for PLAK SMACKER, a class I device, cleared for Plak Smacker Toothbrush Co. on under FDA product code EFW (Toothbrush, Manual). FDA records list one 510(k) clearance for Plak Smacker Toothbrush Co. As of , FDA records show no recalls naming K852400.

Clearance record

Decision date
Received
(25 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
Plak Smacker Toothbrush Co. 1237-A W. Sixth St., Corna CA
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