510(k) K200273
- Device
- FREEPRINT Temp
- Applicant
- DETAX GmbH & Co.KG
- 510(k) number
- K200273
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-10-27
- Date received
- 2020-02-04
- 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
- Markus Stratmann
- Address
- Carl-Zeiss-Strasse 4 Ettlingen DE 76275 76275
FDA Registration Numbers#
- 3008494285
- 3006084069
- 3008582406
- 3031841433
- 9681254
- 9681210
- 3039433962
- 2022039
- 3044819802
- 3032911850
- 1018470
- 3006059056
- 9610902
- 3015396763
- 3003120666
- 3023346365
- 3007031098
- 3014289665
- 3015525101
- 3007740664
- 9611514
- 2024312
- 3011649314
- 3006942327
- 3011221537
- 9612352
- 3005904906
- 9616128
- 1281412
- 3006694515
- 2411797
- 3003794907
- 3009409473
- 2244812
- 3008582054
- 9611385
- 3002808149
- 3020841418
- 3015674635
- 1718912
- 3008578884
- 9615399
- 3045891668
- 3010279788
- 3009432160
- 1036212
- 9613953
- 3011824442
- 2087259
- 2437780
- 1937100
- 2921595
- 3024749697
- 3035335007
- 3013543747
- 3003231822
- 1450653
- 2023129
- 9680954
- 3016074824
- 3003775534
- 3032312561
- 3005628474
- 3017674095
- 1000277456
- 3024185724
- 2436986
- 3035693034
- 3045857207
- 3012187973
- 3004967419
- 3022068322
- 1413475
- 1221541
- 3011944170
- 3012494290
- 9680845
- 2523320
- 3008320092
- 1219645
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 |
| K231859 | PrimmaArt | Dentscare Ltda | 2024-11-26 |
| K242559 | Digital Temp | Sprintray, Inc. | 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 |
| K233868 | dima Print Teeth & Temp | Kulzer, LLC | 2024-05-23 |
| 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 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases