510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063704Substantially Equivalent

Britewhite Teeth Whitening System, Model Bw1101

Beks Incorporated, Carol Stream IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063704 is the FDA 510(k) clearance record for BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101, a class I device, cleared for Beks Incorporated on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list one 510(k) clearance for Beks Incorporated. As of , FDA records show no recalls naming K063704.

Clearance record

Decision date
Received
(69 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Beks Incorporated 694 Bluff St. # 104, Carol Stream IL
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