# K240262: BTI Interna 3.0 Dental Implant System UnicCa®

- Pathway: 510(k) (Traditional)
- Applicant: B.T.I. Biotechnology Institute, Sl.
- Decided: Oct 10, 2024 after 253 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: 16 generations back to K960026 (1996). 267 ancestors in all.
No later device cites it as a predicate yet.
0 of 268 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231827: BTI Dental Implant System UnicCa® – Aesthetic Post Abutments, B.T.I. Biotechnology Institute, Sl. (2023) Summary page 5.

## Indications for use
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient’'s mastication function. INTERNA 3.0 UnicCa® implants with a diameter of 3.3 mm are only intended 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. INTERNA 3.0 UnicCa® implants with a diameter of 3.0 mm are only intended for replacement of maxillary lateral incisors and mandibular incisors, and are only intended for delayed loading. INTERNA 3.0 UnicCa® implants with a diameter of 2.5 mm are only indicated for missing mandibular central and lateral incisors, and are only intended for delayed loading. All digitally designed zirconia components for use with Aesthetic Post Abutments are to be sent to a BTI validated milling center for manufacture.

Source page: https://510kreport.com/device/K240262
Methodology: https://510kreport.com/methodology