PrimmaArt
FDA 510(k) K231859 · Dentscare Ltda
510(k) numberK231859
Submission
- Device name
- PrimmaArt
- Applicant
- Dentscare Ltda
Joinville, BR - Received
- June 23, 2023
- 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 |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 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 |
|---|---|---|
| K232994 | Vittra APS Unique FlowEBF · Traditional | 10/18/2024SE |
| K210231 | Vittra APS UniqueEBF · Traditional | 10/14/2021SE |
| K201707 | Opallis, Opallis FlowEBF · Traditional | 12/22/2020SE |
| K192682 | Orthocem, Ortho BiteDYH · Traditional | 08/14/2020SE |
| K191389 | Allcem Veneer APSEBF · Traditional | 02/25/2020SE |
| K191306 | Llis, Vittra APSEBF · Traditional | 12/16/2019SE |
| K183424 | Ambar, Ambar APS, Ambar Universal APSKLE · Traditional | 12/13/2019SE |
| K183465 | Allcem, Allcem CoreEMA · Traditional | 11/02/2019SE |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APSEBF · Traditional | 09/04/2019SE |
Questions and answers
When was PrimmaArt cleared by the FDA?
PrimmaArt (K231859) received a 510(k) decision of Substantially Equivalent on November 26, 2024, 522 days after the submission was received.
What is the product code of K231859?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.