510(k) K233171
- Device
- PF Keep; Cad Cam Keep Block
- Applicant
- Clemde SA DE CV
- 510(k) number
- K233171
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-27
- Date received
- 2023-09-28
- 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
- No
Applicant Contact#
- Contact
- Francisco Cabrera
- Address
- Av La Fortuna 136 Mexico City MX 07800 07800
FDA Registration Numbers#
- 3013934196
- 3008494285
- 9681210
- 3039359767
- 1043617
- 3039433962
- 3033085428
- 3044819802
- 3027303702
- 9610902
- 9680348
- 3005598536
- 3023346365
- 3014289665
- 2954315
- 2024312
- 3009426332
- 3011649314
- 3006942327
- 9612352
- 3003928050
- 3006697692
- 3010368334
- 3010564008
- 2435952
- 3005904906
- 3008910197
- 3006694515
- 2411797
- 3020702076
- 3003794907
- 2950685
- 3009440973
- 3020841418
- 3015674635
- 1420052
- 3008578884
- 3010279788
- 3009432160
- 3011824442
- 9613953
- 2087259
- 2921595
- 3024749697
- 3003231822
- 3015532223
- 9680954
- 3002807050
- 3004935484
- 3016074824
- 3007233968
- 1000303432
- 1000277456
- 3045857207
- 3012187973
- 3022068322
- 1221541
- 3008757014
- 3012494290
- 3005343849
- 2523320
- 3008320092
- 3005350578
- 3009482106
- 1316408
- 3008912871
- 9681199
- 3025124
- 3003103749
- 3003621174
- 2023950
- 3009727738
- 9710611
- 1417846
- 2133714
- 3010002722
- 2530024
- 3004003391
- 3004966444
- 8044164
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 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | 2026-07-01 |
| 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 |