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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 K013227
Device Name SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT
Applicant
Sulzer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Applicant Contact FOSTER BOOP
Correspondent
Sulzer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Correspondent Contact FOSTER BOOP
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/27/2001
Decision Date 11/19/2001
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
Recalls CDRH Recalls
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