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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 K082651
Device Name ENDOSSEOUS DENTAL IMPLANT SYSTEM
Applicant
Southern Implants, Inc.
5 Holland Bldg. 209
Irvine,  CA  92618
Applicant Contact GRETA M HOLS
Correspondent
Southern Implants, Inc.
5 Holland Bldg. 209
Irvine,  CA  92618
Correspondent Contact GRETA M HOLS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/12/2008
Decision Date 12/22/2008
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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