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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 K131682
Device Name UD IMPLANT SYSTEM
Applicant
Medimecca Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
Medimecca Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received06/10/2013
Decision Date 12/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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