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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 K011028
Device Name SCREW-VENT DENTAL IMPLANT SYSTEM
Applicant
Sulzer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Applicant Contact DIANA SMITH
Correspondent
Sulzer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Correspondent Contact DIANA SMITH
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/05/2001
Decision Date 05/21/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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