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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 K202344
Device Name TiUltra Implants and Xeal Abutments
Applicant
Nobel Biocare AB
Box 5190, SE-402 26
Vastra Hamngatan 1,  SE 411 17
Applicant Contact Bernice Jim
Correspondent
Nobel Biocare AB
Box 5190, SE-402 26
Vastra Hamngatan 1,  SE 411 17
Correspondent Contact Bernice Jim
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Codes
NHA   PNP  
Date Received08/18/2020
Decision Date 11/16/2020
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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