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

Sheboygan, WI, US

AMERICAN ORTHODONTICS appears in FDA device records in Sheboygan, WI. FDA records list 46 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
46
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 46 510(k) clearances for American Orthodontics between 1989 and 2026. The busiest year on record is 1989, with 27. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for American Orthodontics, by decision year
YearClearances
198927
19904
19911
19921
19933
20081
20121
20151
20161
20182
20201
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261840BracePaste Prime PlusDYHSubstantially Equivalent
K242537BracePaste Fluoride SealantDYHSubstantially Equivalent
K232011CleoNJMSubstantially Equivalent
K202276BracePaste Band and Build LCDYHSubstantially Equivalent
K181910BracePaste MTP Light Cure PrimerKLESubstantially Equivalent
K172953Acid EtchantKLESubstantially Equivalent
K160782BracePaste AdhesiveDYHSubstantially Equivalent
K143117Wire Sterilization Package with IndicatorsFRGSubstantially Equivalent
K122753EMPOWER CLEARNJMSubstantially Equivalent
K080749RADIANCENJMSubstantially Equivalent
K925012PLASTIC CHAINEJFSubstantially Equivalent
K926578UNI-STICK PLASTIC LIGATURE, MODIFIEDECISubstantially Equivalent
K922984ORTHODONTIC BITELRKSubstantially Equivalent
K923261ORTHODONTIC METAL BRACKETEJFSubstantially Equivalent
K912417MOLAR DISTALIZING ASSEMBLYDYJSubstantially Equivalent
K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERKMYSubstantially Equivalent
K902064MODIFIED UNI-STICK PLASTIC LIGATUREEJFSubstantially Equivalent
K900488MODIFIED X-RING AND SPEED STIX PLASTICE LIGATUREEJFSubstantially Equivalent
K896249BANDTITE GLASS IONOMER CEMENTEMASubstantially Equivalent
K895714ORTHO-KEV APPLIANCE REINFORCING SYSTEMEBISubstantially Equivalent
K895163FORCE IIDYHSubstantially Equivalent
K891331UNI-STICK PLASTIC LIGATURESEJFSubstantially Equivalent
K893482KORN MANDIBULAR ADVANCEREJFSubstantially Equivalent
K893655KOBAYASHI HOOK AND TWIST KOBAYASHI HOOKEJFSubstantially Equivalent
K893555X-RING AND SPEED STIX PLASTIC LIGATURESEJFSubstantially Equivalent
K893550PLASTIC FORCE MODULEEJFSubstantially Equivalent
K893484MULTIPHASE ORTHODONTIC WIREEJFSubstantially Equivalent
K893483BONDABLE RETAINER AND SPACE MAINTAINEREJFSubstantially Equivalent
K893654MEMORY CHAINEJFSubstantially Equivalent
K893549X-RING SEPARATORSEJFSubstantially Equivalent
K893542DIASTEMA CLOSING KITEJFSubstantially Equivalent
K893396AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEMDYHSubstantially Equivalent
K893255SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVEDYHSubstantially Equivalent
K893037NO-MIX 30 ORTHODONTIC BONDING SYSTEMSDYHSubstantially Equivalent
K891775MANDIBULAR LIP BUMPER AND LIP BUMPER TUBESEJFSubstantially Equivalent
K891327NICKLE-TITANIUM ORTHODONTIC WIREFJFSubstantially Equivalent
K891599FILAFLEX ORTHODONTIC WIREEJFSubstantially Equivalent
K890536JASPER JUMPER KITEJFSubstantially Equivalent
K891354ORTHODONTIC COTTON ROLL HOLDERSKHRSubstantially Equivalent
K890656LIP BUMPEREJFSubstantially Equivalent
K891484ORTHODONTIC WRAP-AROUND HAWLEY RETAINEREJFSubstantially Equivalent
K891592ORTHODONTIC ARCH AND SURGICAL HOOKSEJFSubstantially Equivalent
K891372ORTHODONTIC PLASTIC BRACKETDYWSubstantially Equivalent
K891328PREFORMED TEMPLATE FOR TOOTH POSITIONERKMYSubstantially Equivalent
K890581THE CLARK LIP SHIELDEJFSubstantially Equivalent
K89014520/20 ORTHODONTIC CERAMIC BRACKETEJFSubstantially Equivalent

Registered establishments

FDA registered establishments for American Orthodontics, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21266832126683AMERICAN ORTHODONTICS3524 Washington Ave, SHEBOYGAN, WI 53081 US2026and 25 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain