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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 K844351
Device Name OPTI-LITE
Applicant
Innovators, Inc.
2721 D Industrial Dr.
Jefferson City,  MO  65109
Applicant Contact DON C GENTRY
Correspondent
Innovators, Inc.
2721 D Industrial Dr.
Jefferson City,  MO  65109
Correspondent Contact DON C GENTRY
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received11/09/1984
Decision Date 12/21/1984
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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