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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K915511
Device Name MIRAGE COMPLETE KIT AND MIRAGE ABC KIT
Applicant
Mirage Dental Systems
200 N. 6th St.
Kansas City,  KS  66101
Applicant Contact TIMOTHY SIGLER
Correspondent
Mirage Dental Systems
200 N. 6th St.
Kansas City,  KS  66101
Correspondent Contact TIMOTHY SIGLER
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/09/1991
Decision Date 03/06/1992
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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