PMMA Blocks for Dental Use
FDA 510(k) K223477 · Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) numberK223477
Submission
- Device name
- PMMA Blocks for Dental Use
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao, CN - Received
- November 18, 2022
- Decision date
- February 16, 2023
- 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 |
|---|---|---|
| K253036 | Light-curing Coloring Materials (ALCM)EBF · Traditional | 04/06/2026SE |
| K251415 | Additively Manufactured Aligner ResinNXC · Traditional | 08/27/2025SE |
| K250534 | Biomic Color OpaqueEIH · Traditional | 05/20/2025SE |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge ResinEBF · Traditional | 04/30/2025SE |
| K250811 | Dental Zirconia CeramicEIH · Special | 04/11/2025SE |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIH · Traditional | 03/14/2025SE |
| K242884 | Additively Manufactured Denture ResinEBI · Traditional | 11/22/2024SE |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST)EIH · Special | 07/12/2024SE |
| K230115 | Denture Base ResinEBI · Traditional | 03/17/2023SE |
| K223742 | Dental Ceramic BlocksEBF · Traditional | 03/08/2023SE |
Questions and answers
When was PMMA Blocks for Dental Use cleared by the FDA?
PMMA Blocks for Dental Use (K223477) received a 510(k) decision of Substantially Equivalent on February 16, 2023, 90 days after the submission was received.
What is the product code of K223477?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.