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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 K041368
Device Name DENTIUM CO., LTD. IMPLANTIUM
Applicant
Dentium Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Applicant Contact CATHRYN N CAMBRIA
Correspondent
Dentium Co., Ltd.
5536 Trowbridge Dr.
Dunwoody,  GA  30338
Correspondent Contact CATHRYN N CAMBRIA
Regulation Number872.3640
Classification Product Code
DZE  
Date Received05/24/2004
Decision Date 07/29/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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