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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K050260
Device Name BIORESORB MACRO PORE
Applicant
ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH
3234 64TH ST.
LUBBOCK,  TX  79413
Applicant Contact CHAD BARTEE
Correspondent
ORALTRONICS DENTAL IMPLANT TECHNOLOGY GMBH
3234 64TH ST.
LUBBOCK,  TX  79413
Correspondent Contact CHAD BARTEE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/03/2005
Decision Date 07/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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