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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
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact SABINE KRISCHER
Correspondent
3M ESPE DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  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
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