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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K980792
Device Name CU-100A LIGHT CURE UNIT
Applicant
Rolence Enterprise Co. , Ltd.
226 Kong-Shieh-Sir Village
Chungli, Taiwan,  TW
Applicant Contact STERLING CHENG
Correspondent
Rolence Enterprise Co. , Ltd.
226 Kong-Shieh-Sir Village
Chungli, Taiwan,  TW
Correspondent Contact STERLING CHENG
Regulation Number872.3690
Classification Product Code
EBF  
Date Received03/02/1998
Decision Date 05/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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