Premium Teeth Resin
FDA 510(k) K240538 · Formlabs Ohio, Inc.
510(k) numberK240538
Submission
- Device name
- Premium Teeth Resin
- Applicant
- Formlabs Ohio, Inc.
Millbury, OH, US - Received
- February 26, 2024
- Decision date
- July 19, 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 |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| 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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Questions and answers
When was Premium Teeth Resin cleared by the FDA?
Premium Teeth Resin (K240538) received a 510(k) decision of Substantially Equivalent on July 19, 2024, 144 days after the submission was received.
What is the product code of K240538?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.