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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
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