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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 K983120
Device Name BICORTICAL SCREW
Applicant
ORALTRONICS MARKETING-UND VERTRIEBS GMBH
4329 GRAYDON RD.
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
ORALTRONICS MARKETING-UND VERTRIEBS GMBH
4329 GRAYDON RD.
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/04/1998
Decision Date 07/29/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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