510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925163Substantially Equivalent

Micodose Chlorhexiprep

Unicep, Sandpoint ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925163 is the FDA 510(k) clearance record for MICODOSE CHLORHEXIPREP, a class I device, cleared for Unicep on under FDA product code ECM (Band, Preformed, Orthodontic). FDA records list 9 510(k) clearances for Unicep, from to . As of , FDA records show no recalls naming K925163.

Clearance record

Decision date
Received
(226 days to decision)
Product code
ECM Band, Preformed, Orthodontic
Regulation
21 CFR 872.5410
Device class
Class I
Review panel
Dental
Applicant
Unicep P.O. Box 1827, Sandpoint ID
510(k) summary
Statement
Third party review
No

Clearances, product code ECM

Trailing 12 months

FDA records hold no clearances under product code ECM in the trailing twelve months.

FDA records show no clearances under product code ECM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ECM, 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