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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 K860982
Device Name DB PRECISION IMPLANT SYSTEM, 2000 SERIES
Applicant
DRISKELL BIOENGINEERING
A DIVISION OF QUINTRON INC.
5229 CHESHIRE ROAD
GALENA,  OH  43021
Applicant Contact THOMAS D DRISKELL
Correspondent
DRISKELL BIOENGINEERING
A DIVISION OF QUINTRON INC.
5229 CHESHIRE ROAD
GALENA,  OH  43021
Correspondent Contact THOMAS D DRISKELL
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/17/1986
Decision Date 04/25/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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