Manufacturer registered with FDA
Handae Chemical Co., Ltd
Jincheon-gun, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 17
- 510(k) clearances
- 12004–2004
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Handae Chemical Co., Ltd 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 | Handae Chemical Co., Ltd | 1 clearances | 2004–2004 | Below |
| Taiwan | TFDA | Manufacturer | HANDAE CHEMICAL CO., LTD. | 2 | 2010–2011 | Pure Global AI |
| China | NMPA | Registration holder | 韩国韩大凯美克株式会社HANDAE CHEMICAL CO., LTD | 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 Handae Chemical Co., Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Impression MaterialELW · Class 2 | Impression materials | Maker | Delikit Bite Registration PremiumDelikit Heavy Body PremiumDelikit Light Body PremiumPERFECT BITEPERFECT-F VPS FIT CHECKERPERFECT-F VPS HEAVY BODYPERFECT-F VPS LIGHT BODYPERFECT-F VPS PUTTYPERFECT-F VPS REGULAR BODYVINYLATE | 2019 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | PERFECT BITEPERFECT-F VPS FIT CHECKERPERFECT-F VPS HEAVY BODYPERFECT-F VPS LIGHT BODYPERFECT-F VPS PUTTYPERFECT-F VPS REGULAR BODYVINYLATE | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Handae Chemical Co., Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Vericom Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Aug 2014 | K140966 | VONFLEX S BITE | Vericom Co., Ltd. | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HANDAE CHEMICAL CO., LTDFDA reg. 3004605596 | Jincheon-gun Chungbuk, South Korea | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10035933). 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.