Manufacturer registered with FDA
Hass Corp.
Gangneung-si, South Korea. Lists 2 dental device types with FDA across 2 registered establishments, and holds 6 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 10
- 510(k) clearances
- 62010–2026
- Markets registered in
- 316 registrations outside the US
- Establishments
- 2South Korea
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Hass Corp. 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 | Hass Corp. | 6 clearances | 2010–2026 | Below |
| Brazil | ANVISA | Manufacturer | HASS CORPORATIONHASS CORP. | 8 | 2015–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | HASS Corp.HASS CORPORATION · HASS CORP. | 8 | 2016–2025 | 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 Hass Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Amber LiSi-POM SeriesAmber LiSi-POZ SeriesAmber Mill MesoAmber Mill Q Series & Amber Mill Direct SeriesAmber Mill SeriesAmber Press MasterAmber Press SeriesRosetta SMRosetta SP | 2016 |
| Preformed CrownELZ · Class 1 | — | Maker | ZIRKIZ | 2011 |
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 Hass Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Oct 2026 | K262523 | Amber Arte | EIH Porcelain Powder |
| 11 Jun 2026 | K260859 | Rosetta SM, Rosetta SP | EIH Porcelain Powder |
| 26 Aug 2021 | K202952 | Amber Mill Q Series & Amber Mill Direct Series | EIH Porcelain Powder |
| 14 Jul 2016 | K160102 | Amber Mill Series and Amber Press Series | EIH Porcelain Powder |
| 26 Aug 2011 | K111573 | MONOBLOC BM SERIES | EIH Porcelain Powder |
| 3 Dec 2010 | K102305 | HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HASS CORP.FDA reg. 3025604798 | Gangneung-si Gangwon, South Korea | Manufacturer |
| HASS CORP.FDA reg. 3008754429 | Gangneung-si Gangwon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10034719). 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.