# K092112: Bti Dental Implant Tiny 2.5-3.0

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Oct 6, 2009 after 84 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.
- K080396: Osseospeed Narrow, Astra Tech AB (2008) 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 Implant Tiny® 3.0 are intended to be used to restore missing teeth in partially or fully edentulous patients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients. 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/K092112
Methodology: https://510kreport.com/methodology