Aalba Dent, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Aalba Dent, Inc.” (first 1985, latest 2004), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 42 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| EJH | Alloy, Metal, Base | 18 | 18 |
| EJT | Alloy, Gold-Based Noble Metal | 5 | 5 |
| EJS | Alloy, Other Noble Metal | 2 | 2 |
| EJF | Bracket, Metal, Orthodontic | 1 | 1 |
| EJI | Syringe, Cartridge | 1 | 1 |
Review panels
- Dental (27)
Most recent Aalba Dent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040180 | CONTINUM V | EJH | 2004-03-04 | 37 |
| K040179 | CONTINUM | EJH | 2004-03-03 | 36 |
| K033356 | VERASOFT ES | EJH | 2003-12-30 | 101 |
| K982094 | VERABOND 2 | EJH | 1998-07-22 | 37 |
| K972971 | NPG + 2 | EJH | 1998-01-05 | 147 |
| K973265 | VERABOND 2V | EJH | 1997-10-16 | 48 |
| K972607 | PLATALLOY | EJH | 1997-10-10 | 91 |
| K972534 | ALFALLOY | EJS | 1997-09-05 | 60 |
| K972533 | VERA SOLDER | EJS | 1997-09-05 | 60 |
| K972632 | VERA PD SOLDER | EJT | 1997-08-15 | 32 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aalba Dent, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aalba Dent, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Aalba Dent, Inc.” (first 1985, latest 2004), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Aalba Dent, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aalba Dent, Inc. is 42 days.
Which FDA product codes appear under Aalba Dent, Inc.?
The most frequent FDA product codes under this applicant name are EJH (Alloy, Metal, Base, 18); EJT (Alloy, Gold-Based Noble Metal, 5); EJS (Alloy, Other Noble Metal, 2).
Next steps
- See all 27 Aalba Dent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJH, Aalba Dent, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.