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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K925349
Device Name ONE SYSTEM TAPERED TITANIUM ABUTMENTS
Applicant
Implant Support Systems, Inc.
4790 Irvine Blvd.
#105-137
Irvine,  CA  92720
Applicant Contact LYNN CUPERUS
Correspondent
Implant Support Systems, Inc.
4790 Irvine Blvd.
#105-137
Irvine,  CA  92720
Correspondent Contact LYNN CUPERUS
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/22/1992
Decision Date 07/27/1993
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
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