# K163349: MIS V3 Conical Connection Dental Implant System­

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: May 26, 2017 after 178 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: 9 generations back to K894595 (1990). 25 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 4.

## Most influential descendants
- K172505: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments (2017), 4 descendants of its own
- K241692: MIS LYNX Conical Connection Implant System (2024), 2 descendants of its own
- K173326: MIS CONNECT Conical Connection Abutment (2018), 1 descendant of its own
- K251647: MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System (2025), 0 descendants of its own
- K251297: MIS LYNX Conical Connection Implant System (2025), 0 descendants of its own

## Indications for use
MIS V3 Conical Connection Dental Implant System is 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, in order to restore the patient chewing function. 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/K163349
Methodology: https://510kreport.com/methodology