Hexa-Temp
FDA 510(k) K214071 · Spident Co., Ltd.
510(k) numberK214071
Submission
- Device name
- Hexa-Temp
- Applicant
- Spident Co., Ltd.
Gojan-Dong, Namdong-Gu, KR - Received
- December 27, 2021
- Decision date
- March 10, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
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| 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 |
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| 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 |
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Questions and answers
When was Hexa-Temp cleared by the FDA?
Hexa-Temp (K214071) received a 510(k) decision of Substantially Equivalent on March 10, 2022, 73 days after the submission was received.
What is the product code of K214071?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.