Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hiossen, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
226 daysmedian FDA review time
400 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Hea | Hiossen, Inc. | 2026-05-14 | 226 | 0 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 | 266 | 0 |
| K241003 | HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre | Hiossen, Inc. | 2025-01-08 | 271 | 0 |
| K240232 | EK D3.3 and Ultra Wide Implants | Hiossen, Inc. | 2024-09-13 | 228 | 0 |
| K233389 | EK Digital Abutments | Hiossen, Inc. | 2024-05-29 | 240 | 0 |
| K222636 | ET Abutment System | Hiossen, Inc. | 2023-04-28 | 240 | 0 |
| K203360 | EK Implants and Abutments System | Hiossen, Inc. | 2022-01-07 | 417 | 0 |
| K191751 | EM Provisional | Hiossen, Inc. | 2019-12-16 | 168 | 0 |
| K191201 | EM SA Implant System | Hiossen, Inc. | 2019-11-15 | 193 | 0 |
| K183242 | ET IV SA Dental Implants | Hiossen, Inc. | 2019-05-21 | 181 | 0 |
| K180527 | IS3 | Hiossen, Inc. | 2018-05-16 | 77 | 0 |
| K170421 | ET Hybrid Abutment | Hiossen, Inc. | 2018-01-11 | 332 | 0 |
| K162390 | ET Hybrid Abutment | Hiossen, Inc. | 2017-01-30 | 157 | 0 |
| K153332 | ETIII SA Fixture System (O3.2mm) | Hiossen, Inc. | 2016-10-27 | 343 | 0 |
| K151542 | A-Oss | Hiossen, Inc. | 2016-08-03 | 422 | 0 |
| K151626 | ET III Bio-SA Fixture System | Hiossen, Inc. | 2016-07-21 | 400 | 1 |
| K140934 | HIOSSEN IMPLANT SYSTEM | Hiossen, Inc. | 2014-11-12 | 215 | 0 |
| K132067 | MULTI ANGLED ABUTMENT SYSTEM | Hiossen, Inc. | 2013-12-20 | 170 | 0 |
| K123471 | ETII SA FIXTURE SYSTEM | Hiossen, Inc. | 2013-07-05 | 234 | 0 |
| K123627 | ET SMARTFIT ABUTMENT | Hiossen, Inc. | 2013-06-28 | 217 | 0 |
| K112532 | ET II BIO-SA FIXTURE SYSTEM | Hiossen, Inc. | 2012-08-06 | 341 | 0 |
| K103537 | ET III SA ULTRA WIDE SYSTEM | Hiossen, Inc. | 2011-03-10 | 98 | 0 |
| K101096 | HT III SA FIXTURE SYSTEM | Hiossen, Inc. | 2010-10-08 | 171 | 0 |
| K093889 | MODIFICATION TO: HG III ULTRA WIDE SYSTEM | Hiossen, Inc. | 2010-04-22 | 125 | 0 |
| K093352 | HG III FIXTURE SYSTEM | Hiossen, Inc. | 2009-11-24 | 28 | 0 |
| K090237 | HG II FIXTURE SYSTEM | Hiossen, Inc. | 2009-04-17 | 74 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda