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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 K062493
Device Name LAVA SOFTWARE
Applicant
3M Espe AG Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Applicant Contact SABINE KRISCHER
Correspondent
3M Espe AG Dental Products
Espe Platz
Bavaria D-82228 Seefeld,  DE D-82229
Correspondent Contact SABINE KRISCHER
Regulation Number872.3630
Classification Product Code
NHA  
Subsequent Product Code
EIH  
Date Received08/25/2006
Decision Date 11/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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