# K201334: Keystone Dental XL Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Keystone Dental, Inc.
- Decided: Aug 18, 2020 after 90 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). 165 ancestors in all.
No later device cites it as a predicate yet.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071161: Endosseous Dental Implant System, Southern Implants, Inc. (2007) Summary page 4.
- K112795: Paltop Dental Implant System, Paltop Advanced Dental Solutions, Ltd. (2012) Summary page 4.
- K101545: Genesis Implant System, Keystone Dental (2010) Summary page 5.
- K191054: Southern Implants MAX Implant System, Southern Implants (Pty), Ltd. (2019) Summary page 5.

## Indications for use
The XL Dental Implant System is intended for implantation in the maxillary or mandibular molar region where bone exists and the surgeon has determined that the placement of a narrower diameter implant would increase the probability of failure due to poor primary stability, or increased surgical procedures leading to complications. This XL implant system provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Source page: https://510kreport.com/device/K201334
Methodology: https://510kreport.com/methodology