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
Applicant Contact#
- Contact
- Paige Johnson
- Address
- 27800 Lemoyne Rd. Millbury OH US 43447 43447
FDA Registration Numbers#
- 3005665377
- 3044819802
- 2437780
- 3008966075
- 3006084069
- 3015525101
- 2023950
- 3007210751
- 2086043
- 3011511773
- 1221541
- 9681254
- 3026400121
- 3013543747
- 3009432160
- 1000625496
- 9612300
- 9614977
- 1836392
- 3021381014
- 8010711
- 9613375
- 9616065
- 3008347275
- 2320721
- 3039433962
- 3003794907
- 3007031098
- 9681356
- 9681199
- 1410097
- 1937100
- 3035335007
- 3007791519
- 3032911850
- 8030452
- 3008582054
- 3015396763
- 3024227208
- 3014888923
- 3011221537
- 1416675
- 1018470
- 3045857207
- 3005350578
- 9616128
- 3032163716
- 1219645
- 3017183443
- 3004967419
- 4565
- 8021851
- 3022545323
- 1721647
- 2183301
- 3010664129
- 3009312537
- 3011944170
- 3004966444
- 9680845
- 2433919
- 3005628474
- 2081055
- 3008578884
- 3015491441
- 2023129
- 3003120666
- 3011649314
- 3004086252
- 2024980
- 3012494290
- 1417322
- 1000243214
- 3006942327
- 8020994
- 3008912871
- 3011814610
- 3004130302
- 3019596325
- 9680144
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 |
| 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 |