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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
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