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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name material, impression
510(K) Number K120438
Device Name FLASH (DIFFERENT MATERIALS)
Applicant
3M DEUTSCHLAND GMBH
espe platz
seefeld, bavaria, 
Contact desi w soegiarto
Regulation Number872.3660
Classification Product Code
ELW  
Date Received02/13/2012
Decision Date 05/02/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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