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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 K120503
Device Name CMI IMPLANT IS II ACTIVE
Applicant
NEOBIOTECH CO., LTD.
325 N PUENTE ST. UNIT B
BREA,  CA  92821
Applicant Contact APRIL LEE
Correspondent
NEOBIOTECH CO., LTD.
325 N PUENTE ST. UNIT B
BREA,  CA  92821
Correspondent Contact APRIL LEE
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/21/2012
Decision Date 06/18/2012
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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