# K101201: Straight Abutment, 4.2, 4.6, 5.0, 6.4, Implant 6.0, Implant 7.0, Implant 8.0 Model: 002061, 002062, 002063, 002064,

- Pathway: 510(k) (Traditional)
- Applicant: Kat Implants, LLC
- Decided: Apr 13, 2011 after 349 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: 2 generations back to K982925 (1999). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083544: Kat Implant System, Kat Implants, LLC (2009) Summary page 2.

## Most influential descendants
- K122664: Zuga Dental Implant System (2013), 1 descendant of its own
- K171197: Zuga Dental Implant System (2018), 0 descendants of its own
- K112758: Kat Implants System One-Piece Implants 2.5X10 (2012), 0 descendants of its own

## Indications for use
KAT Implant System dental implants and abutments are indicated for restoration of edentulous maxilla and mandible, to provide support for removable dentures, fixed bridges, or to be used as a single tooth replacement. Single or splinted implants can be immediately loaded if good primary stability and appropriate occlusal loading are achieved. The implants can be placed in extraction sites or healed alveolar ridges. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability.

Source page: https://510kreport.com/device/K101201
Methodology: https://510kreport.com/methodology