510(k) K152215
- Device
- DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
- Applicant
- DENTALPLUS GMBH
- 510(k) number
- K152215
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-19
- Date received
- 2015-08-07
- 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
- RALF GERSCHUETZ RUETH
- Address
- Kohlgrub 5 Samerberg DE 83122 83122
FDA Registration Numbers#
- 3004130302
- 3032163716
- 3026400121
- 3021381014
- 3032312561
- 1000243214
- 3014778017
- 3035335007
- 1718912
- 1219645
- 3003310824
- 3003775534
- 3011689956
- 3005942449
- 3015674635
- 3008578884
- 3045857207
- 3010002722
- 4565
- 9611514
- 2436986
- 3030515618
- 1036212
- 2244842
- 9680845
- 9612352
- 3043226252
- 3008582406
- 1410097
- 3023346365
- 2086043
- 3004425647
- 1450653
- 2916735
- 3006113314
- 3008494285
- 9613375
- 8030452
- 8010908
- 3024185724
- 9616065
- 3011511773
- 3004967419
- 9680954
- 9614977
- 1833025
- 3022545323
- 2515379
- 3005628474
- 3004491043
- 2424472
- 3006694515
- 3014289665
- 3010864832
- 3030686055
- 3009482106
- 3012389497
- 1000486347
- 3015978392
- 1215305
- 2023129
- 9613348
- 3004966444
- 2433919
- 3015396763
- 9613953
- 9615399
- 8021851
- 3032378317
- 3008582054
- 3017183443
- 3024749697
- 3008912871
- 3006084069
- 3009409473
- 8044164
- 3014270094
- 9612300
- 3045891668
- 3008320092
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#
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