# K151391: BTI Dental Implant System UnicCa

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: May 2, 2016 after 342 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: 5 generations back to K935544 (1995). 10 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022258: B.T.I. Biotechnology Institute, S.L. Dental Implant System, B.T.I. Biotechnology Institute, Sl. (2003) Summary page 4.
- K053355: Bti Interna Dental Implant System, B.T.I. Biotechnology Institute, Sl. (2006) Summary page 4.
- K091387: Bti Dental Implant 5.5-6.5, B.T.I. Biotechnology Institute, Sl. (2010) Summary page 4.
- K092112: Bti Dental Implant Tiny 2.5-3.0, B.T.I. Biotechnology Institute, Sl. (2009) Summary page 4.

## Most influential descendants
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa (2022), 1 descendant of its own
- K233137: Ticare Dental Implant Systems (2024), 0 descendants of its own
- K232750: BTI Interna Prosthetic Components (2023), 0 descendants of its own
- K202825: BTI Extra-Short Dental Implant System UnicCa (2021), 0 descendants of its own
- K173257: BTI Dental Implant System UnicCa (2018), 0 descendants of its own

## Indications for use
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function. In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations . In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

Source page: https://510kreport.com/device/K151391
Methodology: https://510kreport.com/methodology