510(k) K213339
- Device
- DENU Composite Resin, DENU Flow Resin
- Applicant
- HDI, Inc.
- 510(k) number
- K213339
- Product code
- EBF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-09-23
- Date received
- 2021-10-07
- Regulation
- 872.3690
- Classification name
- Material, Tooth Shade, Resin
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taekyou Kim
- Address
- A-1504, 14, Sagimakgol-Ro, 45 Beon-Gil, Jungwon-Gu Seongnam-Si KR 13209 13209
FDA Registration Numbers#
- 3009482106
- 3008005217
- 3003120666
- 1000272892
- 2022039
- 1223843
- 1013257
- 3009432160
- 8044164
- 3032027578
- 3001124136
- 3004967419
- 1723973
- 1721647
- 9614573
- 3011511773
- 3012421607
- 8030938
- 9616128
- 3027494823
- 8044038
- 3003621174
- 3022545323
- 9680954
- 3043226252
- 1410097
- 3008524225
- 3011148229
- 2024312
- 2411797
- 9612352
- 3026312357
- 3006316962
- 3002807420
- 1000277456
- 3008254125
- 3014683120
- 3012312751
- 9615399
- 3018047916
- 3044819802
- 8031058
- 3014615644
- 3027526455
- 3012389497
- 3010664129
- 3008882689
- 2437780
- 3010131268
- 3017183443
- 2241860
- 3010127342
- 3004086252
- 2433629
- 3022516928
- 9680144
- 3045891668
- 3017374693
- 8030452
- 3013584861
- 9613375
- 3012441963
- 3013012934
- 3008966075
- 8010638
- 3005665377
- 8030067
- 3010419931
- 3015978392
- 3007210751
- 1718476
- 3018283083
- 1413475
- 2515379
- 3008494285
- 3002808149
- 2424472
- 3006805063
- 3009582362
- 2133714
Source Documents#
Other 510(k) Records For Product Code EBF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | 2026-07-01 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | 2026-07-01 |
| K261246 | SRGC-06 | GC America, Inc. | 2026-06-18 |
| K261093 | DIAFIL | DiaDent Group International | 2026-06-02 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | 2026-05-19 |
| K260805 | Dual Core | Vericom Co., Ltd. | 2026-05-11 |
| K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-04-27 |
| K261357 | Grandio disc multicolor | Voco GmbH | 2026-04-27 |
| K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 2026-04-23 |
| K260661 | Midas Restore | Sprintray, Inc. | 2026-04-15 |
| K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2026-04-06 |
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | 2026-03-11 |
| K254245 | ZAFIRA® | New Stetic, SA | 2026-03-03 |
| K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd. | 2026-01-21 |
| K252465 | Any-Core | Mediclus Co., Ltd. | 2025-12-05 |
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