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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 K884137
Device Name MIRAGE BOND
Applicant
Chameleon Dental Products, Inc.
200 N. Sixth St.
Kansas City,  KS  66101
Applicant Contact J SIGLER,CDT
Correspondent
Chameleon Dental Products, Inc.
200 N. Sixth St.
Kansas City,  KS  66101
Correspondent Contact J SIGLER,CDT
Regulation Number872.3200
Classification Product Code
KLE  
Date Received09/30/1988
Decision Date 12/07/1988
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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