# K200906: MINICONE Implant

- Pathway: 510(k) (Traditional)
- Applicant: Medentika GmbH
- Decided: Oct 16, 2020 after 193 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 K031106 (2003). 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)
- K191895: Straumann Mini Implants, Institut Straumann AG (2019) Summary page 4.

## Indications for use
MINICONE are dental implants that are intended for the stabilization of removable dentures. MINICONE Implants ∅2.6 mm are suitable for oral endosteal implantation in the upper and lower jaw of fully or partially edentulous patients. The implants can be placed with immediate function when good primary stability is achieved. Furthermore, they are to be used in combination with the corresponding prosthetic Optiloc® matrix system and individual new or existing Optiloc® compatible overdentures or partial dentures. For mandibular restorations, at least 4 MINICONE Implants should be placed. For maxillary restorations, at least 6 MINICONE Implants should be placed.

Source page: https://510kreport.com/device/K200906
Methodology: https://510kreport.com/methodology