Alpha-Dent: FDA clearances and approvals
Alpha-Dent has 6 FDA 510(k) clearances (first 1991, latest 1994), across 1 product code in 1 review panel. Median 510(k) review time: 226 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 |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 6 | 6 |
Review panels
- Dental (6)
Most recent Alpha-Dent 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE | EBF | 1994-02-03 | 239 |
| K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST | EBF | 1994-01-28 | 233 |
| K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO | EBF | 1994-01-28 | 233 |
| K932827 | ALPHA-DENT CORE BUILDUP PASTE | EBF | 1993-09-23 | 106 |
| K904813 | VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT. | EBF | 1991-05-31 | 218 |
| K904812 | COMPOSITE RESTORATIVE MATERIAL/RADIOPAQUE | EBF | 1991-02-26 | 124 |
Recalls
openFDA lists no recalls under a recalling firm named Alpha-Dent.
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 Alpha-Dent have?
Alpha-Dent has 6 FDA 510(k) clearances (first 1991, latest 1994), across 1 product code in 1 review panel.
How long does FDA take to clear Alpha-Dent's 510(k)s?
The median time from FDA receipt to decision across Alpha-Dent's cleared 510(k)s is 226 days.
What devices does Alpha-Dent make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 6).
Has Alpha-Dent had device recalls?
openFDA lists no recalls under a recalling firm name matching Alpha-Dent. Related entities may recall under other names.
Next steps
- See all 6 Alpha-Dent clearances with predicates and recalls
- Run predicate analysis for product code EBF, Alpha-Dent'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.