510(k) K230341
- Device
- ACRIFIX
- Applicant
- Deltamed GmbH
- 510(k) number
- K230341
- Product code
- EBI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-06
- Date received
- 2023-02-08
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michael Zimmermann
- Address
- Raiffeisenstrasse 8a Friedberg DE 61169 61169
FDA Registration Numbers#
- 8010638
- 8010019
- 1483306
- 3003928050
- 3007126709
- 3010279788
- 3008910197
- 3011532731
- 3004578725
- 3002807050
- 3009426332
- 8010908
- 3009312537
- 3008757014
- 1420052
- 3009482106
- 1417846
- 3024749697
- 3004966444
- 2411797
- 2032112
- 3023346365
- 3013425656
- 3017450159
- 2921595
- 3013934196
- 2183301
- 2433919
- 3004003391
- 2515379
- 1038806
- 3004935484
- 3025124
- 3005665377
- 2242866
- 3009440973
- 1417322
- 1416675
- 1000118628
- 3012187973
- 2014676
- 3004905070
- 3027494823
- 3013551048
- 3012441963
- 2023950
- 3030515618
- 3015532223
- 3003794907
- 3005598536
- 2950685
- 1000625496
- 9610902
- 3008912871
- 3033085428
- 9681199
- 9710611
- 3014888923
- 3003231822
- 3014270094
- 8044164
- 2032807
- 3008569063
- 3005904906
- 3030686055
- 2024312
- 8010711
- 3003756493
- 4565
- 3015674635
- 3011649314
- 3017183443
- 2081055
- 3004086252
- 3003103749
- 2436918
- 3020841418
- 3011511773
- 9616065
- 3021024355
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EBI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |