# K140440: Noris Medical Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: Noris Medical, Ltd.
- Decided: Dec 19, 2014 after 301 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: 15 generations back to K960026 (1996). 248 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 263 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 4.
- K080162: Uno - One Piece Screw-Type Dental Implant, Mis Implants Technologies, Ltd. (2008) Summary page 4.
- K112440: AB Dental Devices Implants and Accessories, A.B. Dental Devices, Ltd. (2012) Summary page 4.
- K132125: A.B. Dental Devices Dental Implants System, A.B. Dental Devices, Ltd. (2014) Summary page 4.
- K061477: Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems, Nobel Biocare AB (2006) Summary page 4.

## Most influential descendants
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K173343: Zygomatic Implant System (2018), 2 descendants of its own
- K210356: Noris Medical Dental Implants System (2022), 1 descendant of its own
- K192651: ZAGA Zygomatic System (2020), 1 descendant of its own

## Indications for use
Noris Medical Ltd 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 immediate loading when good primary stability is achieved and with appropriate occlusal loading. Mono implants are specifically indicated for replacing maxillary lateral incisors and mandibular central and lateral incisors. They are used for immediate, non-occlusal provisionalization in single-tooth restorations. Multiple-unit restorations should be splinted together and may be used immediately when clinically appropriate.

Source page: https://510kreport.com/device/K140440
Methodology: https://510kreport.com/methodology