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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Orthodontic
510(k) Number K072086
Device Name INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM
Applicant
D B Orthodontics, Ltd.
Ryefield Way
Silsden, Keighley
West Yorkshire,  GB BD20 0EF
Applicant Contact ANNA M DYSON
Correspondent
D B Orthodontics, Ltd.
Ryefield Way
Silsden, Keighley
West Yorkshire,  GB BD20 0EF
Correspondent Contact ANNA M DYSON
Regulation Number872.3640
Classification Product Code
OAT  
Date Received07/30/2007
Decision Date 10/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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