TempFIT Temporary Crown and Bridge Resin
FDA 510(k) K251271 · Rizhao Huge Biomaterials Company, Ltd.
510(k) numberK251271
Submission
- Device name
- TempFIT Temporary Crown and Bridge Resin
- Applicant
- Rizhao Huge Biomaterials Company, Ltd.
Rizhao, CN - Received
- April 24, 2025
- Decision date
- June 23, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K261261 | Dura-ArchEBG · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/17/2026SE |
| K253380 | FLNT Base and FLNT TempEBG · Traditional | Liaoning Upcera Co., Ltd. | 03/02/2026SE |
| K243370 | DentaTOOTHEBG · Traditional | Asiga Pty, Ltd. | 05/05/2025SE |
| K243621 | Evoblock, PerléonEBG · Traditional | Evoden Indústria Comércio Importação E Exportação | 04/22/2025SE |
| K243951 | TEMP MASTER, PMMA-based dental resinEBG · Traditional | Taiwan Dental Materials Co., Ltd. | 02/21/2025SE |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
| K241226 | Fixtemp® C&B 4:1EBG · Special | Dreve Denatmid GmbH | 05/31/2024SE |
| K233868 | dima Print Teeth & TempEBG · Traditional | Kulzer, LLC | 05/23/2024SE |
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|---|---|---|
| K252785 | TopCEM Vigor SA Self-Adhesive Resin CementEMA · Traditional | 12/12/2025SE |
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| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | 11/08/2024SE |
| K241204 | TopCEM-Veneer Light Cure Veneer CementEMA · Traditional | 06/28/2024SE |
| K233082 | TopCEM Dual Cure Resin CementEBF · Traditional | 12/22/2023SE |
| K230455 | Enamel Coating ResinEBC · Traditional | 07/25/2023SE |
| K221510 | TrusFIL-Flow Flowable Composite RestorativeEBF · Traditional | 10/12/2022SE |
| K221450 | Phosphoric Acid Etching GelKLE · Traditional | 09/12/2022SE |
| K202063 | TrusFIL Universal Composite RestorativeEBF · Traditional | 10/06/2021SE |
Questions and answers
When was TempFIT Temporary Crown and Bridge Resin cleared by the FDA?
TempFIT Temporary Crown and Bridge Resin (K251271) received a 510(k) decision of Substantially Equivalent on June 23, 2025, 60 days after the submission was received.
What is the product code of K251271?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.