The following data is part of a premarket notification filed by Hdi, Inc. with the FDA for Denu Composite Resin, Denu Flow Resin.
| Device ID | K213339 |
| 510k Number | K213339 |
| Device Name: | DENU Composite Resin, DENU Flow Resin |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HDI, Inc. A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, KR 13209 |
| Contact | Taekyou Kim |
| Correspondent | Taekyou Kim HDI, Inc. A-1504, 14, Sagimakgol-ro, 45 Beon-gil, Jungwon-gu Seongnam-si, KR 13209 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-07 |
| Decision Date | 2022-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D9560ULFNA35 | K213339 | 000 |
| D9560000ULA1 | K213339 | 000 |
| D9560000ULA2 | K213339 | 000 |
| D9560000ULA3 | K213339 | 000 |
| D9560000ULB1 | K213339 | 000 |
| D9560000ULB2 | K213339 | 000 |
| D9560000ULB3 | K213339 | 000 |
| D956000ULA35 | K213339 | 000 |
| D956000ULUD0 | K213339 | 000 |
| D95600ULFNA0 | K213339 | 000 |
| D95600ULFNA1 | K213339 | 000 |
| D95600ULFNA2 | K213339 | 000 |
| D95600ULFNA3 | K213339 | 000 |
| D95600ULFNB1 | K213339 | 000 |
| D95600ULFNB2 | K213339 | 000 |
| D95600ULFNB3 | K213339 | 000 |
| D95600ULFNS0 | K213339 | 000 |
| D95600ULFNU0 | K213339 | 000 |
| D9560000ULA0 | K213339 | 000 |