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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 K914073
Device Name F21(R) DENTAL CEMENT
Applicant
Voco GmbH
C/Onda Resources
790 Washington St., Suite 301
Denver,  CO  80203
Applicant Contact GAIL E GILLENWATER
Correspondent
Voco GmbH
C/Onda Resources
790 Washington St., Suite 301
Denver,  CO  80203
Correspondent Contact GAIL E GILLENWATER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received09/11/1991
Decision Date 10/21/1991
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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