# K200573: BoneTrust Mini Implant System

- Pathway: 510(k) (Abbreviated)
- Applicant: Medical Instinct Deutschland GmbH
- Decided: May 14, 2021 after 435 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: 2 generations back to K072871 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191751: EM Provisional, Hiossen, Inc. (2019) Summary page 5.

## Indications for use
The BoneTrust® Mini and Mini+ Implants are intended to be loaded immediately in partially or fully edentulous mandibles and maxilla to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implant(s). Use of BoneTrust® Mini and Mini+ Implants is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments are intended for use with BoneTrust® Mini / Mini+ Dental Implants to provide support for provisional prosthetic reconstructions during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Mini Esthetic abutments and BoneTrust® Mini Crown Base Abutments is not to exceed one hundred and eighty (180) days. BoneTrust® Mini Ball Attachments are intended to be used with BoneTrust® Mini / Mini+ Dental Implants to support and/or retain provisional removable dental prostheses during the healing phase of permanent endosseous dental implants. Use of BoneTrust® Ball Attachments is not to exceed one hundred and eighty (180) days.

Source page: https://510kreport.com/device/K200573
Methodology: https://510kreport.com/methodology