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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 K142130
Device Name ORAL BOND
Applicant
Steiner Laboratories
1051 Olsen St.
Bldg. 3611
Henderson,  NV  89011
Applicant Contact GREGORY G STEINER
Correspondent
Steiner Laboratories
1051 Olsen St.
Bldg. 3611
Henderson,  NV  89011
Correspondent Contact GREGORY G STEINER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/04/2014
Decision Date 06/06/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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