# K083544: Kat Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Kat Implants, LLC
- Decided: Feb 2, 2009 after 66 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K982925 (1999). 5 ancestors in all.
4 later devices descend from it; 4 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)
- K982925: Laminoss Dental Implant, Impladent, Ltd. (1999) Summary page 2.
- K050712: 4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant, Bicon, Inc. (2005) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2.
- K063779: Osseospeed 4.0S-6MM, Model 24619, Astra Tech, Inc. (2007) Summary page 2.
- K080396: Osseospeed Narrow, Astra Tech AB (2008) Summary page 2.

## Most influential descendants
- 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, (2011), 3 descendants of its own
- 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 is intended to restore edentulous areas of 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 implant 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. KAT 3.0mm implant is indicated for use in maxillary lateral or mandibular lateral and central incisors in single or multiple units to support prosthesis, such as artificial teeth. The implant can be placed in extraction sites or healed alveolar ridges and can be immediately loaded when good primary stability is achieved and the functional load is appropriate. Immediate loading may not be appropriate in Type IV bone due to difficulty in achieving primary stability. KAT 2.5mm is a self-tapping titanium alloy threaded screw indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT 2.5mm may also be used for inter-radicular transitional application.

Source page: https://510kreport.com/device/K083544
Methodology: https://510kreport.com/methodology