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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K092758
Device Name X-CUBE
Applicant
Saeshin Precision Co., Ltd.
#93-15, Paho-Dong, Dalseo-Gu
Daegu,  KR 704-220
Applicant Contact Y.S. LEE
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Correspondent Contact MARC M MOUSER
Regulation Number872.4200
Classification Product Code
EBW  
Date Received09/09/2009
Decision Date 09/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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