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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 K925849
Device Name ZEST IMPLANT ANCHOR
Applicant
Zest Anchors, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Applicant Contact DANIEL J MANELLI
Correspondent
Zest Anchors, Inc.
2000 M St. NW Suite 700
Washington,  DC  20036
Correspondent Contact DANIEL J MANELLI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/18/1992
Decision Date 11/18/1994
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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