510(k) K261474
- Device
- DENTCA Tru Flexible
- Applicant
- Dentca, Inc.
- 510(k) number
- K261474
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-01
- Date received
- 2026-05-04
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Jason Lee
- Address
- 17742 Cowan Irvine CA US 92614 92614
FDA Registration Numbers#
- 3005665377
- 3044819802
- 3008910197
- 3040605150
- 2023950
- 3006697692
- 2530024
- 2032112
- 2086043
- 3011511773
- 1221541
- 9680348
- 3009432160
- 1000625496
- 9612300
- 1483306
- 3021381014
- 8010711
- 9616065
- 3008347275
- 3039433962
- 3003794907
- 3005343849
- 9681356
- 3020702076
- 3033085428
- 2436918
- 9681199
- 3003621174
- 1410097
- 3021024355
- 3007791519
- 2133714
- 9681531
- 3027303702
- 3008569063
- 3016237718
- 1417846
- 8030452
- 3013425656
- 3024227208
- 3027526455
- 3014888923
- 1416675
- 3045857207
- 3005350578
- 3010368334
- 3017183443
- 3046274075
- 1000118628
- 4565
- 8021851
- 3005598536
- 3022545323
- 2183301
- 3010664129
- 3010564008
- 3009312537
- 3003103749
- 2032807
- 3004966444
- 2433919
- 2081055
- 3008578884
- 3015491441
- 3039359767
- 3011649314
- 3004086252
- 2014676
- 3007233968
- 3012494290
- 3009426332
- 1417322
- 3004578725
- 1000243214
- 9710611
- 3006942327
- 3008912871
- 3015532223
- 3013934196
Source Documents#
Other 510(k) Records For Product Code EBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261802 | Glidewellâ„¢ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026-08-27 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | 2026-08-13 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | 2026-07-31 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | 2026-07-08 |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | 2026-06-02 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | 2026-05-06 |
| K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo, Inc. | 2025-11-25 |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | 2025-11-21 |
| K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | 2025-11-20 |
| K252430 | Freeprint® denture flex | Detax GmbH | 2025-10-30 |
| K252035 | DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White) | Kamemizu Chemical Industry Co., Ltd. | 2025-09-17 |
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025-06-25 |
| K242897 | Partial Flex | Clemde SA DE CV | 2025-06-03 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |