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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 K002475
Device Name REPLACE TPS COATED IMPLANTS
Applicant
NOBEL BIOCARE UAS INC
22895 EASTPARK DR.
YORBA LINDA,  CA  92887
Applicant Contact DON KENNARD
Correspondent
NOBEL BIOCARE UAS INC
22895 EASTPARK DR.
YORBA LINDA,  CA  92887
Correspondent Contact DON KENNARD
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/11/2000
Decision Date 11/09/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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