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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement, Dental
510(k) Number K861685
Device Name SUPERLON (UNILON) CARBOXYLATE CEMENT
Applicant
Carlisle Laboratories, Inc.
404 Doughty Blvd.
Inwood,  NY  11696
Applicant Contact MICHAEL STEHN
Correspondent
Carlisle Laboratories, Inc.
404 Doughty Blvd.
Inwood,  NY  11696
Correspondent Contact MICHAEL STEHN
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/02/1986
Decision Date 05/19/1986
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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