FDA.reportPublic FDA data

510(k) K233596

Device
VarseoSmile TriniQ
Applicant
Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG
510(k) number
K233596
Product code
EBF
Decision
Substantially Equivalent (SESE)
Decision date
2023-11-09
Date received
2023-11-08
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
Yes

Applicant Contact#

Contact
Marcel Müller
Address
Wilhelm-Herbst-Straße 1 Bremen DE 28359 28359

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EBF#

510(k), Device, Applicant table
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K261093DIAFILDiaDent Group International2026-06-02
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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