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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 K062292
Device Name UNICEM
Applicant
3M Espe Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact SABINE KRISCHER
Correspondent
3M Espe Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact SABINE KRISCHER
Regulation Number872.3275
Classification Product Code
EMA  
Date Received08/07/2006
Decision Date 10/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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