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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 K955759
Device Name LITEX 680
Applicant
Dentamerica
18320 Bedford Cir.
P.O. Box 3200
Industry,  CA  91744
Applicant Contact J. HUANG
Correspondent
Dentamerica
18320 Bedford Cir.
P.O. Box 3200
Industry,  CA  91744
Correspondent Contact J. HUANG
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received12/18/1995
Decision Date 01/02/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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