CURA-Temp
FDA 510(k) clearance K202965 · decided 2022-12-21
Clearance details
- K-number
- K202965
- Device name
- CURA-Temp
- Applicant
- Mgnewton , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-30
- Decision date
- 2022-12-21
- Days to decision
- 812 days
- Clearance type
- Traditional
- Product code
- EBG
- Device class
- 2
- Regulation number
- 872.3770
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Gyeongsan-Si, KR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dura-Arch (K261261) | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| “FLNT Base” and “FLNT Temp” (K253380) | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| TempFIT Temporary Crown and Bridge Resin (K251271) | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| DentaTOOTH (K243370) | Asiga Pty, Ltd. | 2025-05-05 |
| Evoblock, Perléon (K243621) | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| TEMP MASTER, PMMA-based dental resin (K243951) | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| PrimmaArt (K231859) | Dentscare Ltda | 2024-11-26 |
| Digital Temp (K242559) | Sprintray, Inc. | 2024-11-26 |
| Premium Teeth Resin (K240538) | Formlabs Ohio, Inc. | 2024-07-19 |
| Fixtemp® C&B 4:1 (K241226) | Dreve Denatmid GmbH | 2024-05-31 |
| dima Print Teeth & Temp (K233868) | Kulzer, LLC | 2024-05-23 |
| PMMA BLOCK (K223706) | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
Recalls involving this device
No recalls on record reference this clearance.