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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Activator, Ultraviolet, For Polymerization
510(k) Number K991863
Device Name CUTE-LITE I LIGHT CURE UNIT
Applicant
Rolence Enterprise Co. , Ltd.
18-3 Ln. 231 Pu Chung Rd.
Chungli 320,  TW
Applicant Contact STERLING CHENG
Correspondent
Rolence Enterprise Co. , Ltd.
18-3 Ln. 231 Pu Chung Rd.
Chungli 320,  TW
Correspondent Contact STERLING CHENG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received06/01/1999
Decision Date 07/19/1999
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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