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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
Recalls CDRH Recalls
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