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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 K022265
Device Name LIGHT TIP
Applicant
Svenska Dental Instruments AB
P.O. Box 723
Finvids Vag 8
Upplands Vaesby,  SE 194 27
Applicant Contact EMMA BERGQUIST
Correspondent
Svenska Dental Instruments AB
P.O. Box 723
Finvids Vag 8
Upplands Vaesby,  SE 194 27
Correspondent Contact EMMA BERGQUIST
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received07/12/2002
Decision Date 10/02/2002
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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