510(k) K193113
- Device
- GC Temp Print
- Applicant
- GC America Inc.
- 510(k) number
- K193113
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-07-09
- Date received
- 2019-11-12
- 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
- Mark Heiss
- Address
- 3737 W. 127th St. Alsip IL US 60803 60803
FDA Registration Numbers#
- 3018507299
- 3006084069
- 3010864832
- 3011618875
- 3017674095
- 2523320
- 3005350578
- 3006059056
- 3039433962
- 2027375
- 2515379
- 3032911850
- 3015674635
- 3008922120
- 3026400121
- 3009312537
- 2024980
- 2022039
- 9613375
- 1420089
- 9613953
- 3009409473
- 3003775534
- 3020841418
- 1833025
- 3011814610
- 3010664129
- 9613348
- 3015525101
- 4565
- 3009482106
- 9681199
- 3014615644
- 1530561
- 3013551048
- 3015978392
- 3043226252
- 3024749697
- 3011511773
- 3005628474
- 3032312561
- 3007031098
- 9614977
- 2087259
- 3005942449
- 1036212
- 3023346365
- 3031841433
- 3014270094
- 9616128
- 3016074824
- 3012389497
- 1417322
- 3017374693
- 8044164
- 1000492377
- 3013543747
- 2023129
- 3004130302
- 9615399
- 1410097
- 2183301
- 3008254125
- 1223843
- 3010002722
- 2081055
- 8021851
- 3011649314
- 1413475
- 3022545323
- 3012494290
- 3030515618
- 3015491441
- 8030452
- 9610902
- 1000243214
- 1281412
- 3019596325
- 3004884150
- 3003231822
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