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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 K071851
Device Name HDC STERILE SPIDER SCREW
Applicant
Hdc S.R.L.
Via Calindri 50
S. Lazzaro Di Savena, Bologna,  IT 40068
Applicant Contact GUIDO BONAPACE
Correspondent
Hdc S.R.L.
Via Calindri 50
S. Lazzaro Di Savena, Bologna,  IT 40068
Correspondent Contact GUIDO BONAPACE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/05/2007
Decision Date 10/18/2007
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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