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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 K962733
Device Name CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)
Applicant
Union Broach, Div. Moyco Industries, Inc.
589 Davies Dr.
York,  PA  17402
Applicant Contact CHRIS M LEHR
Correspondent
Union Broach, Div. Moyco Industries, Inc.
589 Davies Dr.
York,  PA  17402
Correspondent Contact CHRIS M LEHR
Regulation Number872.3275
Classification Product Code
EMA  
Date Received07/15/1996
Decision Date 10/11/1996
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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