# K091387: Bti Dental Implant 5.5-6.5

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Jan 22, 2010 after 256 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: 4 generations back to K935544 (1995). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 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 1.
- K053355: Bti Interna Dental Implant System, B.T.I. Biotechnology Institute, Sl. (2006) Summary page 1.
- K063779: Osseospeed 4.0S-6MM, Model 24619, Astra Tech, Inc. (2007) Summary page 1.

## Most influential descendants
- K151391: BTI Dental Implant System UnicCa (2016), 5 descendants of its own
- 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

## Indications for use
BTI Dental implants 5.5 - 6.5 mnm are intended to be used to restore missing teeth in partially or fully edentulous patients and/or for the fixation of overdentures to restore or enhance the chewing capacity of patients. The device should be used in a two-stage surgical procedure. These implants are not indicated for immediate loading. These implants are not indicated to support removable resilient retained restorations or angled abutments.

Source page: https://510kreport.com/device/K091387
Methodology: https://510kreport.com/methodology