Flexible Partial Resin
FDA 510(k) K250302 · Prismatik Dentalcraft, Inc.
510(k) numberK250302
Submission
- Device name
- Flexible Partial Resin
- Applicant
- Prismatik Dentalcraft, Inc.
Irvine, CA, US - Received
- February 3, 2025
- Decision date
- June 25, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
|---|---|---|
| K261802 | Glidewell Denture Base ResinEBI · Traditional | 08/27/2026SE |
| K262239 | Obsidian® Press Over ZirconiaEIH · Special | 07/30/2026SE |
| K254283 | BruxZir® Shaded 16 PLUSEIH · Special | 01/30/2026SE |
| K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…NHA · Traditional | 11/18/2025SE |
| K252446 | BruxZir® NOWEIH · Special | 09/03/2025SE |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant…KCT · Traditional | 03/21/2025SE |
| K250223 | BruxZir® Esthetic NOWEIH · Special | 02/25/2025SE |
| K241493 | Glidewell 3DP Denture Base ResinEBI · Traditional | 09/12/2024SE |
| K240240 | Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…NHA · Traditional | 07/12/2024SE |
| K231940 | BruxZir® NOW SRCNHA · Traditional | 05/15/2024SE |
Questions and answers
When was Flexible Partial Resin cleared by the FDA?
Flexible Partial Resin (K250302) received a 510(k) decision of Substantially Equivalent on June 25, 2025, 142 days after the submission was received.
What is the product code of K250302?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.