510(k) K061530
- Device
- MD-TEMP
- Applicant
- META BIOMED CO., LTD.
- 510(k) number
- K061530
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-07-21
- Date received
- 2006-06-02
- 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
- TAE-HOON KIM
- Address
- 414-12 Mochoong-Dong Cheongju City, Chungbuk KR 361-140 361-140
FDA Registration Numbers#
- 2018957
- 3008494285
- 8020994
- 3008912871
- 3005628474
- 3011824442
- 9613953
- 3013551048
- 3017183443
- 3006942327
- 3014289665
- 1215305
- 3003756493
- 9612352
- 3004130302
- 3010864832
- 3012187973
- 1833025
- 3008578884
- 3008347275
- 2320721
- 3010279788
- 1281412
- 3030686055
- 9610902
- 2027375
- 3008922120
- 3004086252
- 3003310824
- 3003775534
- 3003231822
- 3013543747
- 1000243214
- 9680954
- 3009727738
- 3009496224
- 2081055
- 2244842
- 3043226252
- 9616128
- 3012441963
- 3022068322
- 3032163716
- 3014270094
- 9681254
- 3014888923
- 2086043
- 2411797
- 3038718579
- 3006059056
- 3004491043
- 3005350578
- 3008254125
- 3009482106
- 3015674635
- 2280629
- 3009409473
- 3011618875
- 8010711
- 1223843
- 3035693034
- 3015491441
- 3008966075
- 1018470
- 3032911850
- 9613348
- 1417322
- 3024749697
- 1000492377
- 3030515618
- 9613375
- 1221541
- 3011944170
- 8021851
- 3031841433
- 1416675
- 3002789526
- 3026312357
- 3004425647
- 2424472
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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