510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K883761Substantially Equivalent

Ionodent II (6 Volts)

U.S. Apatite Corp., Canoga Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883761 is the FDA 510(k) clearance record for IONODENT II (6 VOLTS), a class I device, cleared for U.S. Apatite Corp. on under FDA product code EFW (Toothbrush, Manual). FDA records list 2 510(k) clearances for U.S. Apatite Corp., from to . As of , FDA records show no recalls naming K883761.

Clearance record

Decision date
Received
(90 days to decision)
Product code
EFW Toothbrush, Manual
Regulation
21 CFR 872.6855
Device class
Class I
Review panel
Dental
Applicant
U.S. Apatite Corp. 7841 Alabama Ave., Canoga Park 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