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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 K782080
Device Name VENEER SYSTEM, MOSTIQUE LAMINATE
Applicant
Caulk Co., Div. Dentsply
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Caulk Co., Div. Dentsply
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3200
Classification Product Code
KLE  
Date Received12/13/1978
Decision Date 01/26/1979
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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