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510(k) Data Aggregation
K Number
K052553Device Name
NITOM LOCKING FACEBOW
Manufacturer
RUSSELL SAMUELS ORTHODONTIC DESIGN
Date Cleared
2005-12-22
(97 days)
Product Code
DZB
Regulation Number
872.5500Why did this record match?
Applicant Name (Manufacturer) :
RUSSELL SAMUELS ORTHODONTIC DESIGN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. It has two catches or locks on the inner bow to prevent it accidentally coming out at night.
Device Description
The Nitom Locking facebow is a type of orthodontic facebow used in Orthodontic treatment with a neckstrap or headcap to hold or move the upper back teeth backwards. The Nitom Facebow has two catches or locks on the inner bow to prevent it accidentally coming out at night. It is attached to extra oral traction tubes of the patients fixed orthodontic appliance on the upper first molars. It is usually worn by the patient in the evening and at night. It improves the anchorage of the upper back teeth. It is made of stainless steel.
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