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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K120011
Device Name HEISENBERG EFFECT SHADES
Original Applicant
3M ESPE AG
espe platz
seefeld,  DE 82229
Original Contact desi w soegiarto
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/03/2012
Decision Date 01/13/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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