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
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K042153Substantially Equivalent

South Beach Smile Light Whitening System

Dentovations, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042153 is the FDA 510(k) clearance record for SOUTH BEACH SMILE LIGHT WHITENING SYSTEM, a class I device, cleared for Dentovations, Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list one 510(k) clearance for Dentovations, Inc. As of , FDA records show no recalls naming K042153.

Clearance record

Decision date
Received
(91 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Dentovations, Inc. 12101 Cullen Blvd., Houston TX
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