Core-Vent Corp.: FDA clearances and approvals
Core-Vent Corp. has 25 FDA 510(k) clearances (first 1986, latest 2000), across 2 product codes in 1 review panel. Median 510(k) review time: 165 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 24 | 24 |
| EFS | Unit, Oral Irrigation | 1 | 1 |
Review panels
- Dental (25)
Most recent Core-Vent Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K002614 | ADVENT IMPLANT SYSTEM | DZE | 2000-12-08 | 108 |
| K002188 | SWISSPLUS IMPLANT SYSTEM, MODEL SPWB 8,10,12,14/OPH20/SMPR, SPB 8,10,12,14/OP3.5D/OPAR,OPB 8,10,12,14/OP2.3D/OP2.8D, | DZE | 2000-10-30 | 102 |
| K950579 | MICRO-VENT IMPLANT | DZE | 1995-07-11 | 165 |
| K950578 | SCREW-VENT IMPLANT | DZE | 1995-07-11 | 165 |
| K950577 | SWEDE-VENT IMPLANT | DZE | 1995-07-11 | 165 |
| K950576 | BIO-VENT X IMPLANT | DZE | 1995-07-11 | 165 |
| K950575 | BIO-VENT IMPLANT | DZE | 1995-07-11 | 165 |
| K912059 | PRE-ANGLED ABUTMENTS | DZE | 1992-02-11 | 278 |
| K913782 | TCAL ABUTMENT | DZE | 1991-10-30 | 75 |
| K910585 | TSIR ANGLED ABUTMENTS | DZE | 1991-10-04 | 235 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Core-Vent 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 Core-Vent Corp. have?
Core-Vent Corp. has 25 FDA 510(k) clearances (first 1986, latest 2000), across 2 product codes in 1 review panel.
How long does FDA take to clear Core-Vent Corp.'s 510(k)s?
The median time from FDA receipt to decision across Core-Vent Corp.'s cleared 510(k)s is 165 days.
What devices does Core-Vent Corp. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 24); EFS (Unit, Oral Irrigation, 1).
Has Core-Vent Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Core-Vent Corp. Related entities may recall under other names.
Next steps
- See all 25 Core-Vent Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Core-Vent 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.