510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Allesee Orthodontic Appliances, Inc.

Sturtevant, WI, US

Allesee Orthodontic Appliances, Inc. appears in FDA device records in Sturtevant, WI. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Allesee Orthodontic Appliances, Inc. between 2004 and 2010. The busiest year on record is 2004, with 1. The most recent is 2010, with 1.

Clearances by year, as a table
510(k) clearance decisions for Allesee Orthodontic Appliances, Inc., by decision year
YearClearances
20041
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K093821FS ALIGNERNXCSubstantially Equivalent
K040874RED, WHITE & BLUENXCSubstantially Equivalent

Registered establishments

FDA registered establishments for Allesee Orthodontic Appliances, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
21840451000128562Allesee Orthodontic Appliances, Inc.13931 Spring St, Sturtevant, WI 53177 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1314-2014AOA Distalizer Lock Nut Screw, found in products listed as: Distal Jet, Spring Jet, Mesial Jet, and Uprighter Jet. Removable functional orthodontic appliances that are to modify the growth of the jaws in a prescribed growth pattern.The Lock Nut component of the Jet appliances may be missing the screw collar, which serves as a mechanical stop to prevent over-tightening in appliance assemby. Without this collar, an over-tightened lock nut may stop the piston assembly from moving freely, subsequently preventing intended movement of the teeth.Class IITerminated

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