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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 K992236
Device Name LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA
Applicant
Lysta A/S
Gammelgaardsvej 102
Farum,  DK DK-3520
Applicant Contact GREGERS LYSTAGER
Correspondent
Lysta A/S
Gammelgaardsvej 102
Farum,  DK DK-3520
Correspondent Contact GREGERS LYSTAGER
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received07/02/1999
Decision Date 08/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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