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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 K023545
Device Name ULTRA-LITE 200E LIGHT CURE UNIT
Applicant
Rolence Ent., Inc.
18-3 Lane 231 Pu Chung Rd.
Chungli,  TW 320
Applicant Contact STERLING CHENG
Correspondent
Rolence Ent., Inc.
18-3 Lane 231 Pu Chung Rd.
Chungli,  TW 320
Correspondent Contact STERLING CHENG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received10/22/2002
Decision Date 12/30/2002
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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