510(k) K920425

Device
3M BRAND RESTORATIVE Z100
Applicant
3M COMPANY
510(k) number
K920425
Product code
EBF  
Decision
Substantially Equivalent (SESE)
Decision date
1992-03-20
Date received
1992-02-03
Regulation
872.3690
Classification name
Material, Tooth Shade, Resin
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Related Records

Applicant Contact

Contact
SCOTT T ERICKSON
Address
3m Center Bldg. 275-3se-08 St. Paul MN US 55144 55144

FDA Registration Numbers

Source Documents

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EBF  

510(k)DeviceApplicantDecision date
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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

Legacy Summary

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FDA Review

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