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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 K011520
Device Name RESTORE-X
Applicant
First Scientific Limited
7 Roseheyworth Business Park
Abertillery
Blaenau Gwent, Wales,  GB NP13 1SP
Applicant Contact ADE AKINMADE
Correspondent
First Scientific Limited
7 Roseheyworth Business Park
Abertillery
Blaenau Gwent, Wales,  GB NP13 1SP
Correspondent Contact ADE AKINMADE
Regulation Number872.3275
Classification Product Code
EMA  
Date Received05/17/2001
Decision Date 07/23/2001
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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