510(k) K223477
- Device
- PMMA Blocks for Dental Use
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
- 510(k) number
- K223477
- Product code
- EBG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-02-16
- Date received
- 2022-11-18
- 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
- Chen Yingying
- Address
- #56 Tianchi Rd., Economic And Technological Development Zone Qinhuangdao CN 066004 066004
FDA Registration Numbers#
- 2523320
- 3015525101
- 3023346365
- 1000492377
- 3008582406
- 9613375
- 8030452
- 9610902
- 9680954
- 3008922120
- 2433919
- 3010864832
- 3008347275
- 3009482106
- 1223843
- 3010664129
- 2921595
- 1721647
- 3003756493
- 3010002722
- 3005665377
- 3015674635
- 1450653
- 3001389926
- 3014615644
- 4565
- 3045891668
- 3019596325
- 3002789526
- 3011221537
- 9681356
- 3018507299
- 9616128
- 3009727738
- 3008254125
- 3004491043
- 3015396763
- 3038718579
- 3005904906
- 2018957
- 2280629
- 1410097
- 3008578884
- 3024749697
- 3011824442
- 3008494285
- 2024980
- 2086043
- 3035335007
- 3045857207
- 2087259
- 3008582054
- 9613953
- 3009312537
- 1018470
- 3012421607
- 1219645
- 2027375
- 2437780
- 3027494823
- 2081055
- 3002808149
- 3032378317
- 3009432160
- 9611385
- 2244812
- 2916735
- 3006694515
- 1000277456
- 3003794907
- 9614977
- 3007210751
- 3009409473
- 8044164
- 2424472
- 3011814610
- 3026400121
- 3007740664
- 9612352
- 3012389497
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 |
| 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 |