Paltop Advanced Dental Solutions, Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Paltop Advanced Dental Solutions, Ltd.” (first 2012, latest 2025), across 1 product code in 1 review panel. Median 510(k) review time under this name: 207 days. Since 2017 the median was 269 days, against 217 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 |
|---|---|---|
| 2012 | 1 | 207 |
| 2013 | 2 | 140 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 315 |
| 2022 | 1 | 121 |
| 2023 | 0 | — |
| 2024 | 1 | 258 |
| 2025 | 1 | 280 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Paltop Advanced Dental Solutions, Ltd. took a median 269 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 217 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
Review panels
- Dental (7)
Most recent Paltop Advanced Dental Solutions, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243983 | Paltop Dental Implant System | DZE | 2025-09-29 | 280 |
| K232740 | Paltop Short Implants | DZE | 2024-05-22 | 258 |
| K220200 | Paltop Conical Implant System | DZE | 2022-05-25 | 121 |
| K210117 | Paltop Narrow Implant | DZE | 2021-11-30 | 315 |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | DZE | 2013-08-27 | 186 |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | DZE | 2013-08-22 | 94 |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | DZE | 2012-04-20 | 207 |
Recalls
8 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2021-07-26.
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 Paltop Advanced Dental Solutions, Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Paltop Advanced Dental Solutions, Ltd.” (first 2012, latest 2025), across 1 product code 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 Paltop Advanced Dental Solutions, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Paltop Advanced Dental Solutions, Ltd. is 207 days. Since 2017: 269 days, versus 217 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Paltop Advanced Dental Solutions, Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7).
Next steps
- See all 7 Paltop Advanced Dental Solutions, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Paltop Advanced Dental Solutions, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.