Liaoning Upcera Co., Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Liaoning Upcera Co., Ltd.” (first 2014, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 122 days. Since 2017 the median was 134 days, against 115 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 3 | 118 |
| 2015 | 1 | 122 |
| 2016 | 0 | — |
| 2017 | 1 | 146 |
| 2018 | 1 | 123 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 90 |
| 2024 | 1 | 257 |
| 2025 | 0 | — |
| 2026 | 2 | 91 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Liaoning Upcera Co., Ltd. took a median 134 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EIH | Powder, Porcelain | 7 | 7 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (10)
Most recent Liaoning Upcera Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253380 | FLNT Base and FLNT Temp | EBG | 2026-03-02 | 153 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | EIH | 2026-01-09 | 29 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | KLE | 2024-10-02 | 257 |
| K231687 | Gradual Dental Zirconia Blank | EIH | 2023-09-07 | 90 |
| K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | EIH | 2018-09-02 | 123 |
| K162323 | Tooth Shade Resin Material | EBF | 2017-01-12 | 146 |
| K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | EIH | 2015-12-04 | 122 |
| K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) | EIH | 2014-12-18 | 175 |
| K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK | EIH | 2014-10-22 | 118 |
| K141723 | UPCERA COLORING LIQUID (I AND II ) | EIH | 2014-10-22 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Liaoning Upcera 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Liaoning Kampo Medical System Co., Ltd. (1 510(k)s)
- Liaoning Rachcera Material Technology Co., Ltd. (1 510(k)s)
- Liaoning Shengjingtang Biotechnology Co., Ltd. (1 510(k)s)
- Liaoning Sidey Optoelectronics Technologies Co., Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Liaoning Upcera Co., Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Liaoning Upcera Co., Ltd.” (first 2014, latest 2026), across 4 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 Liaoning Upcera Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Liaoning Upcera Co., Ltd. is 122 days. Since 2017: 134 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Liaoning Upcera Co., Ltd.?
The most frequent FDA product codes under this applicant name are EIH (Powder, Porcelain, 7); EBF (Material, Tooth Shade, Resin, 1); EBG (Crown And Bridge, Temporary, Resin, 1).
Next steps
- See all 10 Liaoning Upcera Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EIH, Liaoning Upcera 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.