510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K041392Substantially Equivalent

Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White US

Cao Group, Inc., Sandy UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041392 is the FDA 510(k) clearance record for SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US, a class I device, cleared for CAO Group, Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list 33 510(k) clearances for CAO Group, Inc., from to . As of , FDA records show no recalls naming K041392.

Clearance record

Decision date
Received
(167 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
CAO Group, Inc. 8683 S. 700 W., Sandy UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code EEG

Trailing 12 months

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

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