Manufacturer registered with FDA
HDI Inc.
Seongnam-si, South Korea. Lists 14 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 14
- Brands and models
- 25
- 510(k) clearances
- 22022–2022
- Markets registered in
- 311 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name HDI Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | HDI Inc. | 2 clearances | 2022–2022 | Below |
| Taiwan | TFDA | Manufacturer | HDI INC. | 10 | 2017–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | HDI Inc. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What HDI Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | DENU Composite ResinDENU Flow Resin | 2022 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | DENU Composite ResinDENU Flow Resin | 2022 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Denu Block-Out ResinDenu Jig HandyDenu Jig PasteDenu TemTooth | 2023 |
| Articulation PaperEFH · Class 1 | — | Maker | Denu Shim Stock | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Denu Dual Tray PA; Denu Dual Tray PB; Denu Dual Tray P1; Denu Dual Tray P2Denu Dual Tray UL; Denu Dual Tray LL; Denu Dual Tray UM; Denu Dual Tray LM; Denu Dual Tray US; Denu Dual Tray LS | 2023 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | Denu DamDenu Fil Flow | 2023 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | Denu Plastic Probe | 2023 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Denu Pumice Paste | 2023 |
| Root Canal Endodontic PreparerEKQ · Class 1 | Endodontic files | Maker | Denu EDTA Cream | 2023 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | DENU Heavy Body(Regular, Fast)DENU Light Body(Regular, Fast)DENU Putty Set(Regular, Fast) | 2022 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Denu GingiCord | 2023 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | Denu Fluoride Gel Tray | 2023 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Denu Stick Free | 2023 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Denu Bite Block CoverDenu Digital Sensor CoverDenu Intraoral Camera Cover | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names HDI Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 7 Nov 2022 | K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | ELW Impression Material |
| 23 Sep 2022 | K213339 | DENU Composite Resin, DENU Flow Resin | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: DSI Dental Solutions Ltd (2).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HDI INC.FDA reg. 3025307990 | Seongnam-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086700). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.