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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 K053354
Device Name INTERMEZZO PLUS FIXTURE
Applicant
Megagen Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Applicant Contact DAE CHANG
Correspondent
Megagen Co., Ltd.
13340 E Firestone Blvd.
Suite J
Santa Fe Springs,  CA  90670
Correspondent Contact DAE CHANG
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/02/2005
Decision Date 04/13/2006
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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