Apoza Enterprise Co., Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Apoza Enterprise Co., Ltd.” (first 2003, latest 2007), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| ELC | Scaler, Ultrasonic | 1 | 1 |
Review panels
- Dental (5)
Most recent Apoza Enterprise Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | EBZ | 2007-03-02 | 22 |
| K041303 | LED TURBO-PEN | EBZ | 2004-06-18 | 32 |
| K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | ELC | 2004-04-30 | 211 |
| K040618 | LED TURBO | EBZ | 2004-03-25 | 16 |
| K033201 | LA500 BLUE LIGHT | EBZ | 2003-12-02 | 61 |
Recalls
openFDA lists no recalls under a recalling firm named Apoza Enterprise Co., Ltd..
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 Apoza Enterprise Co., Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Apoza Enterprise Co., Ltd.” (first 2003, latest 2007), across 2 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 Apoza Enterprise Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Apoza Enterprise Co., Ltd. is 32 days.
Which FDA product codes appear under Apoza Enterprise Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 4); ELC (Scaler, Ultrasonic, 1).
Next steps
- See all 5 Apoza Enterprise Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Apoza Enterprise Co., Ltd.'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.