Digital Temp
FDA 510(k) K242559 · Sprintray, Inc.
510(k) numberK242559
Submission
- Device name
- Digital Temp
- Applicant
- Sprintray, Inc.
Los Angeles, CA, US - Received
- August 28, 2024
- Decision date
- November 26, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 06/23/2025SE |
| 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 |
| 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 |
More from Kulzer, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K260661 | Midas RestoreEBF · Traditional | 04/15/2026SE |
| K250617 | Apex FlexEBI · Traditional | 04/29/2025SE |
| K242277 | Crown HTEBF · Traditional | 10/01/2024SE |
| K230445 | OnX ToughEBI · Traditional | 07/14/2023SE |
| K222623 | Digital CrownEBF · Traditional | 12/14/2022SE |
| K221678 | SprintRay High Impact Denture BaseEBI · Traditional | 11/10/2022SE |
| K220979 | SprintRay Denture BaseEBI · Traditional | 09/14/2022SE |
| K212448 | NightGuard FlexMQC · Traditional | 11/12/2021SE |
Questions and answers
When was Digital Temp cleared by the FDA?
Digital Temp (K242559) received a 510(k) decision of Substantially Equivalent on November 26, 2024, 90 days after the submission was received.
What is the product code of K242559?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.