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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 K972006
Device Name ACTA OEM MODULE
Applicant
Interactive Consulting, Inc.
70 Walnut St.
Wellesley,  MA  02481
Applicant Contact JACKIE MASSE
Correspondent
Interactive Consulting, Inc.
70 Walnut St.
Wellesley,  MA  02481
Correspondent Contact JACKIE MASSE
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received05/30/1997
Decision Date 07/10/1997
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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