# K192149: MIS Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Dec 11, 2019 after 124 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: 10 generations back to K925765 (1993). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180282: MIS Internal Hex Dental Implant System, Mis Implants Technologies, Ltd. (2018) Summary page 4.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.

## Most influential descendants
- K210886: MIS Lance+ Conical Connection Dental Implant System (2021), 0 descendants of its own

## Indications for use
MIS Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another. The long MIS (18 & 20 mm) implants can be used in a tilted manner. MIS short implants are to be used only with straight abutments. MIS short implants are indicated for delayed loading only.

Source page: https://510kreport.com/device/K192149
Methodology: https://510kreport.com/methodology