510(k) K242897
- Device
- Partial Flex
- Applicant
- Clemde SA DE CV
- 510(k) number
- K242897
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-03
- Date received
- 2024-09-23
- 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
Related Records
Applicant Contact
- Contact
- Cabrera Francisco
- Address
- Av La Fortuna 136 Mexico City MX 07800 07800
FDA Registration Numbers
- 3002789526
- 1410097
- 1417322
- 3040605150
- 3001389926
- 3011203516
- 3006942327
- 9612352
- 2916735
- 3039433962
- 3020093493
- 1420052
- 4565
- 3011532731
- 3024227208
- 3012389497
- 3021381014
- 3009727738
- 3030515618
- 9681356
- 3003103749
- 2086043
- 3007791519
- 9680954
- 3009482106
- 9680348
- 2032112
- 3006694515
- 9681531
- 3012187973
- 8030452
- 3014888923
- 3005665377
- 1416675
- 3012441963
- 3008757014
- 9613953
- 3014778017
- 8021851
- 3002807050
- 3014270094
- 3008912871
- 3024749697
- 3015302693
- 3033085428
- 2032807
- 1221541
- 2950685
- 8010908
- 1000118628
- 2424472
- 3003621174
- 3003794907
- 3038718579
- 3027616
- 8031054
- 2411797
- 9681210
- 9681199
- 1043617
- 3026312357
- 3010002722
- 3008494285
- 3017183443
- 3017374693
- 2515379
- 2954315
- 3003756493
- 3007126709
- 3004905070
- 2087259
- 3022068322
- 3032727
- 3006542438
- 8010019
- 9710611
- 3008347275
- 3010564008
- 3016237718
- 3009440973
Source Documents
Other 510(k) Records For Product Code EBI
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 | FreeprintĀ® 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 |
| K250489 | FP3D | Keystone Industries | 2025-05-20 |
| K250617 | Apex Flex | Sprintray, Inc. | 2025-04-29 |
| K243356 | Asiga DentaBASE | Asiga Pty, Ltd. | 2025-04-11 |
| K250946 | Denture Base Resin DT20 | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2025-03-31 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | 2024-12-23 |
| K243336 | Lucitone Digital Print DentureĀ System | Dentsply Sirona, Inc. | 2024-12-17 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-11-22 |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | 2024-10-24 |