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510(k) Data Aggregation
K Number
K112585Device Name
TOUAREG CLOSEFIT DENTAL IMPANT SYSTEM
Manufacturer
ADIN DENTAL IMPLANTS SYSTEM LTD
Date Cleared
2012-05-24
(261 days)
Product Code
DZE, CLA, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ADIN DENTAL IMPLANTS SYSTEM LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
Device Description
Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
The Touareg CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System. K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. Also, lengths and diameters were added - implants are now provided in diameter of 4.3mm, and lengths of 15.0 mm and 18.0 mm.
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K Number
K081751Device Name
ADIN DENTAL IMPLANTS SYSTEM
Manufacturer
ADIN DENTAL IMPLANTS SYSTEM LTD
Date Cleared
2008-12-19
(183 days)
Product Code
DZE, NHA
Regulation Number
872.3640Why did this record match?
Applicant Name (Manufacturer) :
ADIN DENTAL IMPLANTS SYSTEM LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.
Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading
Device Description
Not Found
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