510(k) K230410
- Device
- DD medical polymers (PMMA)
- Applicant
- Dental Direkt GmbH
- 510(k) number
- K230410
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-23
- Date received
- 2023-02-15
- Regulation
- 872.3760
- Classification name
- Resin, Denture, Relining, Repairing, Rebasing
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Patrick Berz
- Address
- Industriezentrum 106-108 Spenge DE 32139 32139
FDA Registration Numbers#
- 2523320
- 3004935484
- 9710611
- 2950685
- 3004905070
- 3023346365
- 3005598536
- 1038806
- 8030452
- 9610902
- 3027526455
- 9680954
- 2433919
- 2436918
- 3008347275
- 3009482106
- 1223843
- 3010664129
- 2954315
- 2921595
- 3003756493
- 3010002722
- 3003103749
- 3005665377
- 3015674635
- 3001389926
- 4565
- 3002789526
- 9681356
- 8031054
- 3009727738
- 3038718579
- 3008254125
- 9681531
- 3032727
- 3005904906
- 3010564008
- 2280629
- 3004003391
- 1410097
- 3003928050
- 3008578884
- 2435952
- 3006542438
- 3024749697
- 1420052
- 8030870
- 3011824442
- 3008494285
- 2086043
- 3045857207
- 2032807
- 2087259
- 3013934196
- 3005344553
- 9613953
- 3009312537
- 3010368334
- 3012421607
- 3039359767
- 3027494823
- 2081055
- 3009426332
- 3009432160
- 2916735
- 3006694515
- 1000277456
- 3003794907
- 8044164
- 2424472
- 3017450159
- 1000118628
- 3004578725
- 3011532731
- 9612352
- 3012389497
- 3013343038
- 1000625496
- 3008912871
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 |