Hass Corp.: FDA clearances and approvals
Hass Corp. has 5 FDA 510(k) clearances (first 2010, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time: 109 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 177 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 330 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 87 |
Review time against the same product codes
Since 2017, Hass Corp.'s cleared 510(k)s took a median 208 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 5 | 5 |
Review panels
- Dental (5)
Most recent Hass Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260859 | Rosetta SM, Rosetta SP | EIH | 2026-06-11 | 87 |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | EIH | 2021-08-26 | 330 |
| K160102 | Amber Mill Series and Amber Press Series | EIH | 2016-07-14 | 177 |
| K111573 | MONOBLOC BM SERIES | EIH | 2011-08-26 | 81 |
| K102305 | HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P | EIH | 2010-12-03 | 109 |
Recalls
openFDA lists no recalls under a recalling firm named Hass Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hass Corp. have?
Hass Corp. has 5 FDA 510(k) clearances (first 2010, latest 2026), across 1 product code in 1 review panel.
How long does FDA take to clear Hass Corp.'s 510(k)s?
The median time from FDA receipt to decision across Hass Corp.'s cleared 510(k)s is 109 days.
What devices does Hass Corp. make?
Its most frequent FDA product codes are EIH (Powder, Porcelain, 5).
Has Hass Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hass Corp. Related entities may recall under other names.
Next steps
- See all 5 Hass Corp. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Hass Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.