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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name agent, tooth bonding, resin
510(k) Number K033974
Device Name HERMES BOND
Applicant
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact ANDREAS PETERMANN
Correspondent
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact ANDREAS PETERMANN
Regulation Number872.3200
Classification Product Code
KLE  
Subsequent Product Code
EMA  
Date Received12/22/2003
Decision Date 02/06/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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