510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895174Substantially Equivalent

Union Broach Bleaching Light

Union Broach, Div. Moyco Industries, Inc., Emigsville PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895174 is the FDA 510(k) clearance record for UNION BROACH BLEACHING LIGHT, a class I device, cleared for Union Broach, Div. Moyco Industries, Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list 14 510(k) clearances for Union Broach, Div. Moyco Industries, Inc., from to . As of , FDA records show no recalls naming K895174.

Clearance record

Decision date
Received
(249 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Union Broach, Div. Moyco Industries, Inc. P.O. Box 508, Emigsville PA
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