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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 K875243
Device Name DB PRECISION IMPLANT SYSTEM, 2000 SERIES W/HAC
Applicant
Driskell Bioengineering
A Division Of Quintron Inc.
5229 Cheshire Rd.
Galena,  OH  43021
Applicant Contact THOMAS DRISKELL
Correspondent
Driskell Bioengineering
A Division Of Quintron Inc.
5229 Cheshire Rd.
Galena,  OH  43021
Correspondent Contact THOMAS DRISKELL
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/22/1987
Decision Date 02/26/1988
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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