# K182313: BoneTrust Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medical Instinct Deutschland GmbH
- Decided: Mar 11, 2019 after 196 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: 14 generations back to K894595 (1990). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150938: Straumann® Dental Implant System ¿ Roxolid® SLA Implants, Straumann USA, LLC (2015) Summary page 5.

## Indications for use
BoneTrust® Dental Implants are medical devices intended to be surgically placed in the bone of the maxillary and/or mandibular arches to provide support for prosthetic restorations (crowns, bridges or overdenture) in edentulous or partially edentulous patients to restore a patients’ chewing function. BoneTrust® implants can also be used for immediate loading when sufficient primary stability is achieved and with appropriate occlusal loading. BoneTrust® Short Dental Implants with length 6.5 mm are intended for delayed loading only BoneTrust® Abutments and Prosthetic parts are intended for use with Bone Trust Dental Implants in the maxillary and/or mandibular arches to provide support for crowns, bridges or overdenture for edentulous or partially edentulous patients.

Source page: https://510kreport.com/device/K182313
Methodology: https://510kreport.com/methodology