# K182228: MIS LOCKiT Abutments System, OT-Equators and Ball Attachments

- Pathway: 510(k) (Traditional)
- Applicant: Mis Implants Technologies, Ltd.
- Decided: Jan 28, 2019 after 165 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- 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 K894595 (1990). 97 ancestors in all.
No later device cites it as a predicate yet.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163349: MIS V3 Conical Connection Dental Implant System­, Mis Implants Technologies, Ltd. (2017) Summary page 4.
- K172505: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments, Mis Implants Technologies, Ltd. (2017) Summary page 4.
- K180282: MIS Internal Hex Dental Implant System, Mis Implants Technologies, Ltd. (2018) Summary page 4.

## 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 & UNO) 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. M4 short implants are indicated for delayed loading only.

Source page: https://510kreport.com/device/K182228
Methodology: https://510kreport.com/methodology