510(k) K261261
- Device
- Dura-Arch
- Applicant
- Hangzhou SHINING3D Dental Technology Co., Ltd.
- 510(k) number
- K261261
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-17
- Date received
- 2026-04-16
- Regulation
- 872.3770
- Classification name
- Crown And Bridge, Temporary, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Y
Applicant Contact#
- Contact
- Yuqi Chen
- Address
- 9-5-2, Tri-River Valley, Wenyan St., Xiaoshan Hangzhou CN 311258 311258
FDA Registration Numbers#
- 1721647
- 3003310824
- 3010664129
- 9680954
- 3011649314
- 3012421607
- 9680845
- 3026312357
- 2437780
- 1416675
- 9611385
- 2244812
- 2081055
- 2018957
- 3009409473
- 3015396763
- 3017674095
- 2183301
- 8044164
- 3026400121
- 3008578884
- 3007791519
- 3014289665
- 3024185724
- 8030452
- 3006694515
- 9612300
- 9681210
- 3005665377
- 3043226252
- 3032378317
- 1836392
- 9610902
- 1000492377
- 3015978392
- 3022545323
- 2022039
- 3014270094
- 2023129
- 3008320092
- 3011689956
- 3014615644
- 3022068322
- 3007031098
- 1000625496
- 3006059056
- 1000486347
- 1530561
- 2086043
- 2024312
- 3012187973
- 3019596325
- 3035693034
- 3017374693
- 2280629
- 3001389926
- 3004425647
- 3018507299
- 3002808149
- 3008582406
- 3004966444
- 2523320
- 2244842
- 3006942327
- 9680144
- 3005628474
- 2424472
- 3002789526
- 3008922120
- 3030686055
- 9681199
- 3044819802
- 3010864832
- 1018470
- 3011814610
- 3017183443
- 3003120666
- 9613375
- 2023950
- 3032163716
Source Documents#
Other 510(k) Records For Product Code EBG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 |