# K112758: Kat Implants System One-Piece Implants 2.5X10

- Pathway: 510(k) (Traditional)
- Applicant: Kat Implants, LLC
- Decided: Feb 23, 2012 after 154 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 K960026 (1996). 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)
- K083544: Kat Implant System, Kat Implants, LLC (2009) Summary page 2.
- 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,, Kat Implants, LLC (2011) 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.
- K032351: The Maestro System 3.0MM Diameter Implant, BioHorizons Implant Systems, Inc. (2003) Summary page 2.

## Cited in the summary but kept off the family tree
- K990027: Omnicorder, Model 464, Del Mar Avionics (1999). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
KAT Implants 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. KAT Implants System 2.5mm implants are self-tapping titanium alloy threaded screws indicated for transitional and long-term intra-bony applications, such as providing support for transitional or long term crowns, bridges and dentures. KAT Implants System 2.5mm implants may also be used for inter-radicular transitional application. KAT Implants System 3.0mm implants are 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. KAT Implants System Abutments are intended to be used with KAT Implants System Dental Implants aid in prosthetic rehabilitation of the edentulous areas in maxilla and mandible.

Source page: https://510kreport.com/device/K112758
Methodology: https://510kreport.com/methodology