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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 K052471
Device Name HDC SPIDER SCREW
Applicant
Hdc S.R.L.
6512 Bannockburn Dr.
Bethesda,  MD  20817
Applicant Contact MILLIE LYNN BENTLEY
Correspondent
Hdc S.R.L.
6512 Bannockburn Dr.
Bethesda,  MD  20817
Correspondent Contact MILLIE LYNN BENTLEY
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/08/2005
Decision Date 12/23/2005
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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