Glidewell Denture Base Resin
FDA 510(k) K261802 · Prismatik Dentalcraft, Inc.
510(k) numberK261802
Submission
- Device name
- Glidewell Denture Base Resin
- Applicant
- Prismatik Dentalcraft, Inc.
Irvine, CA, US - Received
- June 1, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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 |
| K252430 | Freeprint® denture flexEBI · Traditional | Detax GmbH | 10/30/2025SE |
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| K252446 | BruxZir® NOWEIH · Special | 09/03/2025SE |
| K250302 | Flexible Partial ResinEBI · Traditional | 06/25/2025SE |
| 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 Glidewell Denture Base Resin cleared by the FDA?
Glidewell Denture Base Resin (K261802) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 87 days after the submission was received.
What is the product code of K261802?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.