K241131

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

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 AT
Product code
EBF — Material, Tooth Shade, Resin
Decision date
2024-10-18
Date received
2024-04-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Dental
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain

Also available from FDA: K241131.pdf

Official FDA record: K241131
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.