510(k) K232559
- Device
- C&B NFH Hybrid
- Applicant
- Arum Dentistry Co., Ltd.
- 510(k) number
- K232559
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-09-11
- Date received
- 2023-08-23
- 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
- N
Related Records
Applicant Contact
- Contact
- Boyeon Lim
- Address
- 23 Gukjegwahak 11-Ro, Yuseong-Gu Daejeon KR 34002 34002
FDA Registration Numbers
- 3025307990
- 3003114027
- 3008912871
- 3006805063
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- 3015189878
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- 3012996495
- 2027375
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08809924581013 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08809924581006 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08809924580993 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08809924580986 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08809924580979 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
| 08809924580962 | C&B NFH Hybrid | ARUM DENTISTRY Co., Ltd. | 2026-03-10 |
Other 510(k) Records For Product Code EBF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K260152 | Smart 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 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | 2025-11-07 |
| K253236 | G-BLOCK | Graphenano Dental S.L. | 2025-09-29 |
| K253053 | Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-09-23 |
| K251946 | G aenial Universal Injectable II | GC America, Inc. | 2025-08-29 |
| K251283 | Once-Fil Flow | Mediclus Co., Ltd. | 2025-06-06 |
| K250317 | EsFlow PLUS | Spident Co., Ltd. | 2025-05-30 |