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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K241131
Device Name edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK
Applicant
Edelweiss Dentistry Products GmbH
Dammstrasse 68
Wolfurt,  AT 6922
Applicant Contact Jakob Unterweger
Correspondent
Medagent GmbH
Griesweg 47
Mühlheim An Der Donau,  DE 78570
Correspondent Contact Leonie Zeller
Regulation Number872.3690
Classification Product Code
EBF  
Date Received04/24/2024
Decision Date 10/18/2024
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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