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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K070228
Device Name IMPLANTIUM PROSTHETICS
Applicant
DENTIUM CO., LTD.
5536 TROWBRIDGE DR
ATLANTA,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
DENTIUM CO., LTD.
5536 TROWBRIDGE DR
ATLANTA,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/24/2007
Decision Date 11/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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