# K151588: maxFit II Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Implant Technology Company, Ltd.
- Decided: Apr 25, 2016 after 319 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: 8 generations back to K894595 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083805: Ankylos C/X Dental Implant System, Dentsply Intl., Inc. (2009) Summary page 4.

## Indications for use
maxFiT II Dental Implant System is for single-stage or two-stage surgical procedures and cemented or screw retained restorations. maxFiT II Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. Multiple tooth applications may be splinted with a bar.

Source page: https://510kreport.com/device/K151588
Methodology: https://510kreport.com/methodology