Ab Ardent: FDA clearances and approvals
Ab Ardent has 13 FDA 510(k) clearances (first 1998, latest 2013), across 4 product codes in 1 review panel. Median 510(k) review time: 77 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 153 |
| 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
| EJJ | Alloy, Amalgam | 5 | 5 |
| EMA | Cement, Dental | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (13)
Most recent Ab Ardent 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131753 | MERIDIAN | EBF | 2013-11-14 | 153 |
| K040465 | LATIT FLOW | EBF | 2004-07-20 | 148 |
| K022971 | MICROHYBRID 11 | EBF | 2002-11-25 | 80 |
| K022975 | ETCHING 15 | EBF | 2002-11-22 | 77 |
| K022974 | MICROHYBRID 12 | EBF | 2002-11-22 | 77 |
| K022973 | ADHESIVE 14 | KLE | 2002-11-22 | 77 |
| K022972 | MICROFILL 13 | EBF | 2002-11-22 | 77 |
| K020452 | HIGH SILVER CONVENTIONAL | EJJ | 2002-05-07 | 85 |
| K011801 | FUTURA TOPCAP NON GAMMA-2 | EJJ | 2001-08-16 | 69 |
| K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | EMA | 1999-09-17 | 98 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ab Ardent.
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 Ab Ardent have?
Ab Ardent has 13 FDA 510(k) clearances (first 1998, latest 2013), across 4 product codes in 1 review panel.
How long does FDA take to clear Ab Ardent's 510(k)s?
The median time from FDA receipt to decision across Ab Ardent's cleared 510(k)s is 77 days.
What devices does Ab Ardent make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 6); EJJ (Alloy, Amalgam, 5); EMA (Cement, Dental, 1).
Has Ab Ardent had device recalls?
openFDA lists no recalls under a recalling firm name matching Ab Ardent. Related entities may recall under other names.
Next steps
- See all 13 Ab Ardent clearances with predicates and recalls
- Run predicate analysis for product code EBF, Ab Ardent'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.