510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900991Substantially Equivalent

Sunpak Aqua Floss 2000 Cordless Personal Oral Jet

Tocad America, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900991 is the FDA 510(k) clearance record for SUNPAK AQUA FLOSS 2000 CORDLESS PERSONAL ORAL JET, a class I device, cleared for Tocad America, Inc. on under FDA product code EFS (Unit, Oral Irrigation). FDA records list one 510(k) clearance for Tocad America, Inc. As of , FDA records show no recalls naming K900991.

Clearance record

Decision date
Received
(74 days to decision)
Product code
EFS Unit, Oral Irrigation
Regulation
21 CFR 872.6510
Device class
Class I
Review panel
Dental
Applicant
Tocad America, Inc. 1150 17th St., NW, Washington DC
Third party review
No

Clearances, product code EFS

Trailing 12 months

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

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