# K220200: Paltop Conical Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Paltop Advanced Dental Solutions, Ltd.
- Decided: May 25, 2022 after 121 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K960026 (1996). 95 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210117: Paltop Narrow Implant, Paltop Advanced Dental Solutions, Ltd. (2021) Summary page 4.

## Most influential descendants
- K243983: Paltop Dental Implant System (2025), 0 descendants of its own
- K232383: iPhysio® System (2025), 0 descendants of its own

## Indications for use
The Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K220200
Methodology: https://510kreport.com/methodology