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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 K770113
Device Name ESTILUX UV SYSTEM
Applicant
Degussa Dental, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Degussa Dental, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number872.6070
Classification Product Code
EBZ  
Date Received01/19/1977
Decision Date 01/28/1977
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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