Apoza Enterprise Co., Ltd.
Hsin-Chuang District New Taipei, TW
APOZA ENTERPRISE CO., LTD. appears in FDA device records in Hsin-Chuang District New Taipei, TW. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Apoza Enterprise Co., Ltd. between 2003 and 2007. The busiest year on record is 2004, with 3. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2004 | 3 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K070373 | APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W | EBZ | Substantially Equivalent | |
| K041303 | LED TURBO-PEN | EBZ | Substantially Equivalent | |
| K033198 | APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2 | ELC | Substantially Equivalent | |
| K040618 | LED TURBO | EBZ | Substantially Equivalent | |
| K033201 | LA500 BLUE LIGHT | EBZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9680864 | 1000493876 | APOZA ENTERPRISE CO., LTD. | 6F, NO.657, Chung-Cheng Road, Hsin-Chuang District New Taipei 24257 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain