# K233137: Ticare Dental Implant Systems

- Pathway: 510(k) (Abbreviated)
- Applicant: Mozograu S.A.
- Decided: May 16, 2024 after 232 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: 6 generations back to K935544 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151391: BTI Dental Implant System UnicCa, B.T.I. Biotechnology Institute, Sl. (2016) Summary page 5.

## Indications for use
Ticare Dental Implant Systems are endosseous dental implants intended to be implanted in the maxilla or mandible jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro and InHex Quattro implants are indicated to support permanently fixed restorations. Ticare Inhex and Osseous implants of 6 mm length are intended for use in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.

Source page: https://510kreport.com/device/K233137
Methodology: https://510kreport.com/methodology