# K131451: Paltop Dental Implant - Sterile Accessories

- Pathway: 510(k) (Special)
- Applicant: Paltop Advanced Dental Solutions, Ltd.
- Decided: Aug 22, 2013 after 94 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: 12 generations back to K960026 (1996). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112795: Paltop Dental Implant System, Paltop Advanced Dental Solutions, Ltd. (2012) Summary page 1.

## Indications for use
The Paltop Dental implant System Is Indicated for use In surgical and restorative applications for placement In the bone of the upper or tower jaw to provide support for prosthetic devices, such as artificial teeth, In order to restore the patient's chewing function. The Paltop Dental Implant System Is Indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K131451
Methodology: https://510kreport.com/methodology