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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K051501
Device Name ZIRACE
Applicant
Acucera, Inc.
Namyangju-Si
Gyeonggi
Seul,  KR 472-861
Applicant Contact KYUNG-BIN LEE
Correspondent
Acucera, Inc.
Namyangju-Si
Gyeonggi
Seul,  KR 472-861
Correspondent Contact KYUNG-BIN LEE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received06/06/2005
Decision Date 10/19/2005
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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