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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 K022424
Device Name REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162
Applicant
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Applicant Contact RICHARD T ROSS
Correspondent
NOBEL BIOCARE UAS INC
22715 SAVI RANCH PKWY.
YORBA LINDA,  CA  92887
Correspondent Contact RICHARD T ROSS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/24/2002
Decision Date 09/27/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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