# K113113: Endosseous Dental Implant

- Pathway: 510(k) (Traditional)
- Applicant: Ot Medical GmbH
- Decided: Nov 16, 2012 after 393 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: 3 generations back to K902435 (1991). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053242: Pitt-Easy Dental Implant System, Innova Life Sciences Corp. (2006) Summary page 1.
- K926354: Endo-Pore Endosseous Dental Implant System, Innova Corp. (1995) Summary page 4.
- K971196: Endopore Endosseous Dental Implant System, Innova Corp. (1997) Summary page 4.
- K032140: 5.0 X 5MM Endopore Endosseous Dental Implant System, Innova Life Sciences Corp. (2003) Summary page 4.

## Indications for use
The OT-F73 Implant System is intended to be implanted in the upper or lower jaw arches to provide support far fixed or removable dental prostheses In a single tooth, partially edlentulous prostheses, or full arch prostheses. It is suitable for insertion in completely healed jaw bone (late implantation).

Source page: https://510kreport.com/device/K113113
Methodology: https://510kreport.com/methodology