FDA applicant
Paltop Advanced Dental Solutions, Ltd.
FDA records 7 decisions for Paltop Advanced Dental Solutions, Ltd. (Caesarea, IL) from 2012 to 2025: 7 510(k) clearances. All are in product code DZE (Implant, Endosseous, Root-Form). Since 2016 its 510(k)s took a median of 269 days from receipt to decision, against 203 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 5 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Paltop Advanced Dental Solutions, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
6in 2019
Class I Class II/III not classified
Planning a device like Paltop Advanced Dental Solutions, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report