# K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Sep 15, 2023 after 86 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: 15 generations back to K960026 (1996). 266 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 269 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 4.

## Most influential descendants
- K240262: BTI Interna 3.0 Dental Implant System UnicCa® (2024), 0 descendants of its own
- K232750: BTI Interna Prosthetic Components (2023), 0 descendants of its own

## Indications for use
The BTI Interna Dental Implant System UnicCa® - 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 implants. All digitally designed zirconia components for use with Square Aesthetic Abutments and Aesthetic Interfaces for Transepithelials are to be sent to a BTI validated milling center for manufacture.

Source page: https://510kreport.com/device/K231827
Methodology: https://510kreport.com/methodology