510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K915576Substantially Equivalent

Hubuka Hyg Toothbrush

Hukuba Dental Corp., Nagareyama City, Chiba, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K915576 is the FDA 510(k) clearance record for HUBUKA HYG TOOTHBRUSH, a class I device, cleared for Hukuba Dental Corp. on under FDA product code MMD (Toothbrush, Ionic, Battery-Powered). FDA records list 2 510(k) clearances for Hukuba Dental Corp., from to . As of , FDA records show no recalls naming K915576.

Clearance record

Decision date
Received
(813 days to decision)
Product code
MMD Toothbrush, Ionic, Battery-Powered
Regulation
21 CFR 872.6865
Device class
Class I
Review panel
Dental
Applicant
Hukuba Dental Corp. 914-1 Nazukari, Nagareyama City, Chiba, JP
510(k) summary
Statement
Third party review
No

Clearances, product code MMD

Trailing 12 months

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

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