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510(k) Data Aggregation
K Number
K120861Device Name
FIN-S MICROIMPLANT
Manufacturer
Date Cleared
2013-02-21
(336 days)
Product Code
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
CREEKSIDE ORTHODONTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fin-S Orthodontic/Dental Microimplant is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth in adolescents greater than 12 years of age and adults. The devices are used temporarily and are removed after orthodontic treatment has been completed. This device is intended for single use only.
Device Description
The Fin-S Orthodontic/Dental Microimplant is composed of Titanium-6 Aluminum-4 Vanadium Alloy Grade 5 (ATSM F1472-08, ISO 5832-2:1999) material. It has been designed specifically for orthodontic or dental use and has a head which includes two round holes for insertion of various ligatures, coil springs, and elastomers. It also includes two rectangular slots which accept various forms of orthodontic archwires. The smaller diameter of implant, allows its insertion into many areas of the upper and lower jaws and between the roots of teeth. It is divided into four groups of various lengths. Round Head (6,8,10,12mm), Palatal (4,6,8,10mm), Reverse Thread (6,8,10,12mm), and Long Head (6,8,10,12mm). The round head design is the primary device which includes all of the design elements. The Palatal design is essentially the same as the Round Head Design, but has a shortened soft tissue collar. The Reverse Thread design is the same as the basic Round Head Design but has threads that are reversed and allow for counter-clockwise insertion. Finally, The Long Head design is the same as the basic Round Head Design, but has a lengthened soft tissue collar.
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