510(k) K233868
- Device
- dima Print Teeth & Temp
- Applicant
- Kulzer, LLC
- 510(k) number
- K233868
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-23
- Date received
- 2023-12-06
- Regulation
- 872.3770
- Classification name
- Crown And Bridge, Temporary, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Vincent
- Address
- 4315 S Lafayette Blvd. South Bend IN US 46614 46614
FDA Registration Numbers#
- 3024227208
- 4565
- 3012441963
- 1416675
- 3038718579
- 9611385
- 3008494285
- 3004425647
- 3014778017
- 3032378317
- 3008582406
- 2523320
- 1215305
- 2244842
- 3018507299
- 2024980
- 9680845
- 3005350578
- 1000625496
- 3005942449
- 3017183443
- 9681199
- 8010711
- 1221541
- 2081055
- 2023950
- 3014888923
- 2411797
- 3032911850
- 1223843
- 3008582054
- 3014289665
- 3039433962
- 3024185724
- 3008320092
- 8010908
- 2027375
- 9615399
- 3017674095
- 3002789526
- 3002808149
- 2436986
- 1410097
- 3007210751
- 3035335007
- 3003231822
- 2437780
- 3013543747
- 2921595
- 3009409473
- 3011649314
- 3003120666
- 3021381014
- 3004884150
- 3004130302
- 3020093493
- 3009727738
- 2022039
- 3017374693
- 3004967419
- 8044164
- 3011824442
- 3014615644
- 9612300
- 3008912871
- 3043226252
- 1937100
- 3022068322
- 1018470
- 3007031098
- 3035693034
- 3032312561
- 3012421607
- 3006694515
- 2424472
- 3010664129
- 3003775534
- 9613375
- 3005665377
Source Documents#
Other 510(k) Records For Product Code EBG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-17 |
| K253380 | “FLNT Base” and “FLNT Temp” | Liaoning Upcera Co., Ltd. | 2026-03-02 |
| K251271 | TempFIT Temporary Crown and Bridge Resin | Rizhao Huge Biomaterials Company, Ltd. | 2025-06-23 |
| K243370 | DentaTOOTH | Asiga Pty, Ltd. | 2025-05-05 |
| K243621 | Evoblock, Perléon | Evoden Indústria Comércio Importação E Exportação | 2025-04-22 |
| K243951 | TEMP MASTER, PMMA-based dental resin | Taiwan Dental Materials Co., Ltd. | 2025-02-21 |
| K242559 | Digital Temp | Sprintray, Inc. | 2024-11-26 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 |
| K240538 | Premium Teeth Resin | Formlabs Ohio, Inc. | 2024-07-19 |
| K241226 | Fixtemp® C&B 4:1 | Dreve Denatmid GmbH | 2024-05-31 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | 2023-05-12 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | 2023-02-16 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | 2022-12-21 |
| K214071 | Hexa-Temp | Spident Co., Ltd. | 2022-03-10 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 |