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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 K113554
Device Name CMI IMPLANT IS SYSTEM
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  
Subsequent Product Code
NHA  
Date Received12/01/2011
Decision Date 04/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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