Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Paltop Advanced Dental Solutions, Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
207 daysmedian FDA review time
315 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 | 280 | 0 |
| K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. | 2024-05-22 | 258 | 0 |
| K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022-05-25 | 121 | 0 |
| K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021-11-30 | 315 | 0 |
| K130462 | PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT | Paltop Advanced Dental Solutions, Ltd. | 2013-08-27 | 186 | 0 |
| K131451 | PALTOP DENTAL IMPLANT - STERILE ACCESSORIES | Paltop Advanced Dental Solutions, Ltd. | 2013-08-22 | 94 | 0 |
| K112795 | PALTOP DENTAL IMPLANT SYSTEM | Paltop Advanced Dental Solutions, Ltd. | 2012-04-20 | 207 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda