510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110888Substantially Equivalent

Absolute White Light

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

K110888 is the FDA 510(k) clearance record for ABSOLUTE WHITE LIGHT, a class I device, cleared for Dr. Fresh, Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list 2 510(k) clearances for Dr. Fresh, Inc., from to . As of , FDA records show no recalls naming K110888.

Clearance record

Decision date
Received
(288 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Dr. Fresh, 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