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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 K042466
Device Name X-2 IMPLANT ABUTMENT; BAR MALE; DISTAL EXTENSION MALE
Applicant
Zest Anchors, Inc.
2061 Wineridge Pl., Suite 100
Escondido,  CA  92029
Applicant Contact PAUL ZUEST
Correspondent
Zest Anchors, Inc.
2061 Wineridge Pl., Suite 100
Escondido,  CA  92029
Correspondent Contact PAUL ZUEST
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/13/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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