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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 K033699
Device Name LOCATOR BAR FEMALE, LOCATOR LASER BAR FEMALE, LOCATOR BAR CAST-TO FEMALE, MODELS 08587, 08588, 08586
Applicant
ZEST ANCHORS, INC.
4329 GRAYDON ROAD
SAN DIEGO,  CA  92130
Applicant Contact FLOYD G LARSON
Correspondent
ZEST ANCHORS, INC.
4329 GRAYDON ROAD
SAN DIEGO,  CA  92130
Correspondent Contact FLOYD G LARSON
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/25/2003
Decision Date 04/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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