# K053355: Bti Interna Dental Implant System

- Pathway: 510(k) (Special)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Mar 14, 2006 after 102 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 K935544 (1995). 5 ancestors in all.
11 later devices descend from it; 7 cite it directly.
0 of 17 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 2.

## Most influential descendants
- K091387: Bti Dental Implant 5.5-6.5 (2010), 6 descendants of its own
- K092112: Bti Dental Implant Tiny 2.5-3.0 (2009), 6 descendants of its own
- K151391: BTI Dental Implant System UnicCa (2016), 5 descendants of its own
- K061383: Bti Sterile Dental Drills Kit, Bti Abutments and Caps (2006), 2 descendants of its own
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa (2022), 1 descendant of its own

## Indications for use
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures. The intended use of the system is the restoration of missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.

Source page: https://510kreport.com/device/K053355
Methodology: https://510kreport.com/methodology