Addent, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Addent, Inc.” (first 2005, latest 2019), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 132 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 | 1 | 85 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 276 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Addent, Inc. took a median 276 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 148 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EAZ | Light, Operating, Dental | 2 | 2 |
| NXV | Diagnostic Light, Soft Tissue Detector | 2 | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| NTK | Light Transmission Caries Detector | 1 | 1 |
| QGO | Composite Resin Warmer | 1 | 1 |
Review panels
- Dental (7)
Most recent Addent, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K182017 | Compex HD | QGO | 2019-04-29 | 276 |
| K121282 | MICROLUX/DL MICROLUX/BLU BIO/SCREEN | NXV | 2012-07-24 | 85 |
| K082668 | BIO-SCREEN | NXV | 2009-01-23 | 133 |
| K072309 | MICROLUX/BLU | EAZ | 2007-11-19 | 94 |
| K062961 | MICROLUX TRANSILLUMINATOR | NTK | 2007-02-08 | 132 |
| K061395 | CALSET COMPOSITE HEATER | EBZ | 2006-06-23 | 35 |
| K041614 | MICROLUX DL | EAZ | 2005-04-04 | 293 |
Recalls
openFDA lists no recalls under a recalling firm named Addent, 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 Addent, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Addent, Inc.” (first 2005, latest 2019), 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 Addent, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Addent, Inc. is 132 days.
Which FDA product codes appear under Addent, Inc.?
The most frequent FDA product codes under this applicant name are EAZ (Light, Operating, Dental, 2); NXV (Diagnostic Light, Soft Tissue Detector, 2); EBZ (Activator, Ultraviolet, For Polymerization, 1).
Next steps
- See all 7 Addent, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EAZ, Addent, 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.