# K061383: Bti Sterile Dental Drills Kit, Bti Abutments and Caps

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Aug 3, 2006 after 77 days
- Product code: EJL (Bur, Dental)
- Device class: 1
- Regulation: 21 CFR 872.3240
- 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). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa (2022), 1 descendant of its own
- K232750: BTI Interna Prosthetic Components (2023), 0 descendants of its own

## Indications for use
Dental burs are intended to drill bone tissue and provisionally soft tissues during, before and after a surgical intervention of dental implants. Endosseous dental implant abutments are intended to model the gingival tissue during the process of healing after the first or second surgery and to be attached to the implant to hold single or multiple teeth restorations.

Source page: https://510kreport.com/device/K061383
Methodology: https://510kreport.com/methodology