# K153043: Noris Medical MBI Dental Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Apr 11, 2016 after 175 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Noris Medical Dental Implants System is intended to replace missing tooth/teeth in either jaw for supporting prosthetic devices that may aid in restoring the patient’s chewing function. The procedure can be accomplished in a one-stage or two-stage surgical operation. All implants are appropriate for inmediate loading when good primary stability is achieved and with appropriate occlusal loading. Noris Medical MBI Dental Implant System is One-Piece, self-tapping Implant, with integrated ball attachment, for single-stage implantation to stabilize a tissue-supported denture. MBI is designed for placement in a very narrow ridge.

Source page: https://510kreport.com/device/K153043
Methodology: https://510kreport.com/methodology