FDA.reportPublic FDA data

510(k) K241131

Device
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
510(k) number
K241131
Product code
EBF
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-18
Date received
2024-04-24
Regulation
872.3690
Classification name
Material, Tooth Shade, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jakob Unterweger
Address
Dammstrasse 68 Wolfurt AT 6922 6922

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBF#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261071DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)DiaDent Group International2026-05-19
K260805Dual CoreVericom Co., Ltd.2026-05-11
K261357Grandio disc multicolorVoco GmbH2026-04-27
K261356Dura-CrownHangzhou SHINING3D Dental Technology Co., Ltd.2026-04-27
K260152Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT)Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.2026-04-23
K260661Midas RestoreSprintray, Inc.2026-04-15
K253036Light-curing Coloring Materials (ALCM)Aidite (Qinhuangdao) Technology Co., Ltd.2026-04-06
K260783Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneKulzer, LLC2026-03-11
K254245ZAFIRA®New Stetic, SA2026-03-03
K260170LumiCeraHangzhou SHINING3D Dental Technology Co., Ltd.2026-01-21
K252465Any-CoreMediclus Co., Ltd.2025-12-05
K253513MultiMatch Flow Chameleon AntiMicrobial CompositePremier Dental Products Company2025-11-07
K253236G-BLOCKGraphenano Dental S.L.2025-09-29
K253053Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1)Hangzhou SHINING3D Dental Technology Co., Ltd.2025-09-23
K251946G aenial Universal Injectable IIGC America, Inc.2025-08-29