510(k) K200039
- Device
- P Pro Crown & Bridge
- Applicant
- DeltaMed GmbH
- 510(k) number
- K200039
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-31
- Date received
- 2020-01-08
- 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
- Michael Zimmerman
- Address
- Raiffeisenstrasse 8a Friedberg DE 61169 61169
FDA Registration Numbers#
- 3006084069
- 3007791519
- 2022039
- 9613953
- 3003775534
- 1413475
- 3044819802
- 3004425647
- 3015674635
- 3009312537
- 3002808149
- 9680845
- 2024312
- 1221541
- 1036212
- 8021851
- 1937100
- 3015491441
- 2023950
- 2087259
- 2244812
- 2411797
- 9612352
- 3045857207
- 2183301
- 3010864832
- 3031841433
- 3011814610
- 9610902
- 8044164
- 3038718579
- 9681254
- 3016074824
- 3020841418
- 3009432160
- 3013543747
- 3015396763
- 3008922120
- 3035335007
- 8030452
- 3015525101
- 9681199
- 3008494285
- 2916735
- 3008347275
- 3006459726
- 9614977
- 1215305
- 1000486347
- 3039433962
- 3024185724
- 3005628474
- 1410097
- 3011221537
- 3003310824
- 9680954
- 1000243214
- 3010279788
- 3030686055
- 3004966444
- 9611385
- 1530561
- 3026400121
- 1281412
- 3014270094
- 2081055
- 3006113314
- 3024749697
- 3027494823
- 3008254125
- 1833025
- 4565
- 3011824442
- 3003120666
- 1450653
- 3014615644
- 3017674095
- 1000625496
- 3008582054
- 2027375
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#
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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