# K210117: Paltop Narrow Implant

- Pathway: 510(k) (Traditional)
- Applicant: Paltop Advanced Dental Solutions, Ltd.
- Decided: Nov 30, 2021 after 315 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: 13 generations back to K960026 (1996). 94 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130462: Paltop Narrow Implant, Paltop Short Implant, Paltop Advanced Dental Solutions, Ltd. (2013) Summary page 4.

## Most influential descendants
- K220200: Paltop Conical Implant System (2022), 2 descendants of its own
- K231395: INNO SLA Submerged Narrow Implant System (2023), 1 descendant of its own
- K251605: DIMPLO Implant System (2025), 0 descendants of its own
- 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 Narrow Implant is indicated for use in surgical and restorative applications 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, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K210117
Methodology: https://510kreport.com/methodology
