510(k) K112795 ยท DZE Implant, Endosseous, Root-Form
PALTOP DENTAL IMPLANT SYSTEM
| Applicant | Paltop Advanced Dental Solutions, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Apr 20, 2012 |
| Received | Sep 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 30, 2019 | Paltop Advanced Dental Solutions Ltd Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm
Catalog Number: 20-70024P Terminated |
DZE | None listed |
| Feb 22, 2019 | Keystone Dental Inc Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver
For surgical and restorative applications prosthetic devices, such as artificial teeth
Part Number: 60-70112 Terminated |
DZE | None listed |
| Feb 22, 2019 | Keystone Dental Inc Paltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver
For surgical and restorative applications prosthetic devices, such as artificial teeth
Part Number: 30-70021 Terminated |
DZE | None listed |
| Feb 22, 2019 | Keystone Dental Inc Paltop 1.25 Hex Drivers, Long
Part Number: 60-70101 Terminated |
DZE | None listed |
| Feb 22, 2019 | Keystone Dental Inc Paltop 1.25 Hex Drivers, Short
Part Number: 60-70102 Terminated |
DZE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.