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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 K060500
Device Name SPEEDY ORTHODONTIC SCREW
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 Received02/24/2006
Decision Date 06/16/2006
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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