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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K072055
Device Name LAVA FRAME, LAVA FRAME SHADE
Applicant
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Applicant Contact DESI W SOEGIARTO
Correspondent
3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA,  DE D-82229
Correspondent Contact DESI W SOEGIARTO
Regulation Number872.3630
Classification Product Code
NHA  
Date Received07/26/2007
Decision Date 02/26/2008
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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