510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854692Substantially Equivalent

Monarch II Bleaching Instrument

Almore Intl., Inc., Portland OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854692 is the FDA 510(k) clearance record for MONARCH II BLEACHING INSTRUMENT, a class I device, cleared for Almore Intl., Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list 21 510(k) clearances for Almore Intl., Inc., from to . As of , FDA records show no recalls naming K854692.

Clearance record

Decision date
Received
(172 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Almore Intl., Inc. Post Office Box 25214, Portland OR
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