Hiossen, Inc.: FDA clearances and approvals
Hiossen, Inc. has 26 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time: 222 days. Since 2017 its median was 228 days, against 194 days for all cleared 510(k)s in the same product codes. openFDA lists 7 product recalls by a recalling firm named Hiossen, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 341 |
| 2013 | 3 | 217 |
| 2014 | 1 | 215 |
| 2015 | 0 | — |
| 2016 | 3 | 400 |
| 2017 | 1 | 157 |
| 2018 | 2 | 204 |
| 2019 | 3 | 181 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 417 |
| 2023 | 1 | 240 |
| 2024 | 2 | 234 |
| 2025 | 1 | 271 |
| 2026 | 2 | 246 |
Review time against the same product codes
Since 2017, Hiossen, Inc.'s cleared 510(k)s took a median 228 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 194 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 15 | 15 |
| NHA | Abutment, Implant, Dental, Endosseous | 9 | 9 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 |
| NPM | Bone Grafting Material, Animal Source | 1 | 1 |
Review panels
- Dental (26)
Most recent Hiossen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | NHA | 2026-05-14 | 226 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | NHA | 2026-01-29 | 266 |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) | NHA | 2025-01-08 | 271 |
| K240232 | EK D3.3 and Ultra Wide Implants | DZE | 2024-09-13 | 228 |
| K233389 | EK Digital Abutments | NHA | 2024-05-29 | 240 |
| K222636 | ET Abutment System | NHA | 2023-04-28 | 240 |
| K203360 | EK Implants and Abutments System | DZE | 2022-01-07 | 417 |
| K191751 | EM Provisional | DZE | 2019-12-16 | 168 |
| K191201 | EM SA Implant System | DZE | 2019-11-15 | 193 |
| K183242 | ET IV SA Dental Implants | DZE | 2019-05-21 | 181 |
16 earlier clearances. See the full list in Caduvo.
Recalls
7 product recalls in 2 recall events; 7 initiated in the last five years. Most recent: 2025-01-27.
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 Hiossen, Inc. have?
Hiossen, Inc. has 26 FDA 510(k) clearances (first 2009, latest 2026), across 4 product codes in 1 review panel.
How long does FDA take to clear Hiossen, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hiossen, Inc.'s cleared 510(k)s is 222 days. Since 2017: 228 days, versus 194 days for all cleared 510(k)s in the same product codes.
What devices does Hiossen, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 15); NHA (Abutment, Implant, Dental, Endosseous, 9); EKX (Handpiece, Direct Drive, Ac-Powered, 1).
Has Hiossen, Inc. had device recalls?
openFDA lists 7 product recalls in 2 recall events by a recalling firm whose name matches Hiossen, Inc; the most recent began 2025-01-27. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Hiossen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Hiossen, Inc.'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.