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American Orthodontics

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
45
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242537BracePaste Fluoride SealantAugust 27, 2024
K232011CleoJuly 7, 2023
K202276BracePaste Band and Build LCAugust 14, 2020
K181910BracePaste MTP Light Cure PrimerOctober 15, 2018
K172953Acid EtchantFebruary 6, 2018
K160782BracePaste AdhesiveOctober 14, 2016
K143117Wire Sterilization Package with IndicatorsOctober 29, 2015
K122753EMPOWER CLEARDecember 14, 2012
K080749RADIANCEAugust 4, 2008
K925012PLASTIC CHAINSeptember 13, 1993
K926578UNI-STICK PLASTIC LIGATURE, MODIFIEDMarch 31, 1993
K922984ORTHODONTIC BITEMarch 31, 1993
K923261ORTHODONTIC METAL BRACKETDecember 3, 1992
K912417MOLAR DISTALIZING ASSEMBLYDecember 20, 1991
K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERNovember 9, 1990
K902064MODIFIED UNI-STICK PLASTIC LIGATUREAugust 6, 1990
K900488MODIFIED X-RING AND SPEED STIX PLASTICE LIGATUREJune 1, 1990
K896249BANDTITE GLASS IONOMER CEMENTJanuary 26, 1990
K895714ORTHO-KEV APPLIANCE REINFORCING SYSTEMDecember 21, 1989
K895163FORCE IIOctober 27, 1989