Denture Base Resin
FDA 510(k) K230115 · Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) numberK230115
Submission
- Device name
- Denture Base Resin
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao, CN - Received
- January 17, 2023
- Decision date
- March 17, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
| K261474 | DENTCA Tru FlexibleEBI · Traditional | Dentca, Inc. | 07/01/2026SE |
| K260569 | DB 4000 High Impact Denture BaseEBI · Abbreviated | Carbon, Inc. | 06/02/2026SE |
| K260376 | Denture BaseEBI · Traditional | Shandong Huge Dental Material Corporation | 05/06/2026SE |
| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
More from Guangzhou Heygears IMC., Inc.
| 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 |
| K223742 | Dental Ceramic BlocksEBF · Traditional | 03/08/2023SE |
| K223477 | PMMA Blocks for Dental UseEBG · Traditional | 02/16/2023SE |
Questions and answers
When was Denture Base Resin cleared by the FDA?
Denture Base Resin (K230115) received a 510(k) decision of Substantially Equivalent on March 17, 2023, 59 days after the submission was received.
What is the product code of K230115?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.