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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, Orthodontic
510(k) Number K091390
Device Name HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2
Applicant
HDC S.R.L.
VIA BORGO SANTA CRISTINA,12
IMOLA, BOLOGNA,  IT 4026
Applicant Contact GUIDO BONAPACE
Correspondent
HDC S.R.L.
VIA BORGO SANTA CRISTINA,12
IMOLA, BOLOGNA,  IT 4026
Correspondent Contact GUIDO BONAPACE
Regulation Number872.3640
Classification Product Code
OAT  
Date Received05/11/2009
Decision Date 07/30/2009
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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