# K232750: BTI Interna Prosthetic Components

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Dec 8, 2023 after 91 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 316 ancestors in all.
No later device cites it as a predicate yet.
0 of 317 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213106: BTI Interna Dental Implant System UnicCa - Prosthetic Components, B.T.I. Biotechnology Institute, Sl. (2022) Summary page 5.
- K211952: BTI Interna Narrow/Plus Dental Implant System UnicCa, B.T.I. Biotechnology Institute, Sl. (2022) Summary page 5.
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments, B.T.I. Biotechnology Institute, Sl. (2023). Cleared while this submission was under review Summary page 5.

## Indications for use
The BTI Interna Prosthetic Components are intended to function in the mandible or maxilla to support single and multiple-unit temporary or definitive restorations on the BTI Interna Dental Implant System. All digitally designed zirconia component for use with Aesthetic post abutments are to be sent to a BTI validated milling center for manufacture.

Source page: https://510kreport.com/device/K232750
Methodology: https://510kreport.com/methodology