510(k) K250267
- Device
- Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
- Applicant
- Kettenbach GmbH & Co. KG
- 510(k) number
- K250267
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-14
- Date received
- 2025-01-30
- 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
- Marleen Steger
- Address
- Im Heerfeld 7 Eschenburg DE 35713 35713
FDA Registration Numbers#
- 3012421607
- 3005665377
- 2183301
- 3011649314
- 9680845
- 9681356
- 3006805063
- 3013557697
- 3035693034
- 3011824442
- 3004140838
- 3003310824
- 3007210751
- 8030452
- 1000272892
- 3008912871
- 3013934196
- 9610902
- 2022039
- 3024185724
- 3018507299
- 3030447506
- 3005904906
- 9612300
- 3002789526
- 3022296393
- 3002807050
- 3010419931
- 3017374693
- 2018957
- 2433629
- 2429849
- 3004966444
- 3010664129
- 3015527825
- 8044038
- 1223843
- 3006316962
- 3017674095
- 3003637274
- 3009582362
- 1420089
- 3006542438
- 3030515618
- 2133714
- 3001124136
- 3038718579
- 8010638
- 3014579161
- 2023950
- 3005176727
- 3038715999
- 3009432160
- 3007113445
- 8031058
- 3011148229
- 3000219976
- 8030938
- 3012312751
- 2921595
- 3011511773
- 3024749697
- 3003120666
- 9681210
- 3009496224
- 1450653
- 2244842
- 3014289665
- 3003621174
- 9615399
- 3032163716
- 9680144
- 3004425647
- 1424442
- 3004967419
- 2126683
- 1215305
- 8030067
- 3008582406
Source Documents#
Other 510(k) Records For Product Code EBF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| 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 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| 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 |