Resin for Temporary Crown & Bridge
FDA 510(k) K180657 · Dentis Co., Ltd.
510(k) numberK180657
Submission
- Device name
- Resin for Temporary Crown & Bridge
- Applicant
- Dentis Co., Ltd.
Daegu, KR - Received
- March 13, 2018
- Decision date
- December 7, 2018
- 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 |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
| K241226 | Fixtemp® C&B 4:1EBG · Special | Dreve Denatmid GmbH | 05/31/2024SE |
More from Dreve Denatmid GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | 03/04/2026SE |
| K241065 | ChecQ (AC100)EKX · Traditional | 03/21/2025SE |
| K233921 | Luvis Chair (LC700C)KLC · Traditional | 09/06/2024SE |
| K241063 | s-Clean ScanHealing AbutmentNHA · Traditional | 07/25/2024SE |
| K240511 | Dentis s-Clean SQ-SL FixtureDZE · Traditional | 05/20/2024SE |
| K233544 | MesheetNXC · Traditional | 02/22/2024SE |
| K230126 | Dentis s-Clean Regular AbutmentNHA · Traditional | 08/04/2023SE |
| K230307 | Dentis i-Clean SystemNHA · Traditional | 07/11/2023SE |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional | 05/25/2023SE |
| K230523 | s-Clean Link Abutment NarrowNHA · Traditional | 05/24/2023SE |
Questions and answers
When was Resin for Temporary Crown & Bridge cleared by the FDA?
Resin for Temporary Crown & Bridge (K180657) received a 510(k) decision of Substantially Equivalent on December 7, 2018, 269 days after the submission was received.
What is the product code of K180657?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.