510(k) K240538
- Device
- Premium Teeth Resin
- Applicant
- Formlabs Ohio, Inc.
- 510(k) number
- K240538
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-19
- Date received
- 2024-02-26
- 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
Related Records
Applicant Contact
- Contact
- Paige Johnson
- Address
- 27800 Lemoyne Rd. Millbury OH US 43447 43447
FDA Registration Numbers
- 3008922120
- 3002789526
- 1410097
- 1417322
- 3001389926
- 3005942449
- 3006942327
- 9612352
- 2916735
- 1281412
- 3039433962
- 3017674095
- 3035335007
- 3020093493
- 4565
- 3024227208
- 3015978392
- 3010279788
- 1833025
- 3012389497
- 1420089
- 3021381014
- 3031841433
- 3009727738
- 3019596325
- 3030515618
- 9681356
- 3006459726
- 2086043
- 3007791519
- 9680954
- 3032378317
- 3009482106
- 3006694515
- 3012187973
- 3007740664
- 8030452
- 3014888923
- 2436986
- 3005665377
- 1416675
- 3012441963
- 3014778017
- 9613953
- 8021851
- 1018470
- 3014270094
- 2023129
- 3008912871
- 3024749697
- 3032312561
- 1215305
- 1937100
- 3015302693
- 3004884150
- 3032911850
- 1221541
- 3013543747
- 3004967419
- 8010908
- 3003775534
- 3015491441
- 2424472
- 3007031098
- 3008582406
- 2024980
- 3003794907
- 3038718579
- 9615399
- 3026400121
- 1836392
- 2411797
- 9681210
- 1036212
- 3024185724
- 9681199
- 3010864832
- 3026312357
- 2244812
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 |
| 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 |
| K213643 | UltraPrint-Dental Temp C&B UV | Guangzhou Heygears IMC., Inc. | 2022-01-14 |