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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, Root-Form
510(k) Number K853788
Device Name DB PRECISION IMPLANT SYSTEM
Applicant
Driskell Bioengineering
9040 Hawthorn Pt.
Westerville,  OH  43081
Applicant Contact THOMAS D DRISKELL
Correspondent
Driskell Bioengineering
9040 Hawthorn Pt.
Westerville,  OH  43081
Correspondent Contact THOMAS D DRISKELL
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/10/1985
Decision Date 10/31/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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