# K210886: MIS Lance+ Conical Connection Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Jun 17, 2021 after 84 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: 11 generations back to K925765 (1993). 71 ancestors in all.
No later device cites it as a predicate yet.
0 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192149: MIS Dental Implant System, Dentsply Sirona, Inc. (2019) Summary page 4.

## Indications for use
MIS Dental Implant System is intended to be surgically placed in the bone of the upper and lower jaw arches to provide support for prosthetic device, 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 in appropriate. Narrow implants (@3.3mm) 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.

Source page: https://510kreport.com/device/K210886
Methodology: https://510kreport.com/methodology