DENTCA Tru Flexible
FDA 510(k) K261474 · Dentca, Inc.
510(k) numberK261474
Submission
- Device name
- DENTCA Tru Flexible
- Applicant
- Dentca, Inc.
Irvine, CA, US - Received
- May 4, 2026
- Decision date
- July 1, 2026
- 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 |
| 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 |
More from Detax GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K220042 | Dentca Base Premium, Dentca Base Hi-ImpactEBI · Traditional | 11/17/2022SE |
| K192806 | DENTCA Crown and BridgeEBG · Traditional | 02/05/2020SE |
| K172398 | DENTCA DENTURE TeethPZY · Traditional | 11/22/2017SE |
| K162044 | Dentca Denture Base IIEBI · Traditional | 03/03/2017SE |
| K143033 | Dentca Denture BaseEBI · Traditional | 07/21/2015SE |
Questions and answers
When was DENTCA Tru Flexible cleared by the FDA?
DENTCA Tru Flexible (K261474) received a 510(k) decision of Substantially Equivalent on July 1, 2026, 58 days after the submission was received.
What is the product code of K261474?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.