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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)
Original Applicant
3M DEUTSCHLAND GMBH
espe platz
seefeld, bavaria,  DE d-82229
Original Contact desi w soegiarto
Regulation Number872.3660
Classification Product Code
ELW  
Date Received02/13/2012
Decision Date 05/02/2012
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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