510(k) K261357
- Device
- Grandio disc multicolor
- Applicant
- Voco GmbH
- 510(k) number
- K261357
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-27
- Date received
- 2026-04-24
- 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
- Y
Related Records
Applicant Contact
- Contact
- Katrin Froehlich
- Address
- Anton-Flettner-Str. 1-3 Cuxhaven DE 27472 27472
FDA Registration Numbers
- 3025307990
- 3003114027
- 3008912871
- 3006805063
- 3022296393
- 3022545323
- 8030938
- 3009907932
- 9680144
- 1000303432
- 9612300
- 9613348
- 1032227
- 3003971538
- 3006316962
- 3012627824
- 3011689956
- 2014676
- 3010127342
- 3005665377
- 3035693034
- 3003449480
- 9680845
- 3012312751
- 1215305
- 1013257
- 3016447764
- 3018507299
- 8020994
- 3012187973
- 3004966444
- 9611385
- 1718476
- 1718912
- 8044164
- 3011148229
- 3006223010
- 3000219976
- 3030447506
- 3006367836
- 3001124136
- 3011649314
- 3032027578
- 3007791519
- 3015302693
- 2437780
- 3022516928
- 3008578884
- 3004491043
- 2023950
- 3011814610
- 3009496224
- 3010864832
- 9610902
- 2024980
- 3009582362
- 3009117991
- 3008005217
- 3010131268
- 2916735
- 3004146043
- 1450653
- 3012477813
- 3011221537
- 3014615644
- 1000272892
- 3016074824
- 3017674095
- 3004140838
- 3003310824
- 8031058
- 3004086252
- 8044038
- 1223843
- 9681210
- 3030515618
- 3012421607
- 1000118628
- 3024185724
Source Documents
Other 510(k) Records For Product Code EBF
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| 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 |
| K251578 | BEAUTIFIL II | Shofu Dental Corporation | 2025-05-27 |