# K051719: A.B. Dental Devices

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Devices, Ltd.
- Decided: Mar 21, 2006 after 267 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.
37 later devices descend from it; 4 cite it directly.
0 of 38 devices 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.

## Most influential descendants
- K112440: AB Dental Devices Implants and Accessories (2012), 36 descendants of its own
- K132125: A.B. Dental Devices Dental Implants System (2014), 25 descendants of its own
- K140440: Noris Medical Dental Implants System (2014), 14 descendants of its own
- K151909: Noris Medical Zygomatic Dental Implant System (2016), 7 descendants of its own
- K140728: Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece Implant, Dental Abutments and PR (2014), 6 descendants of its own

## Indications for use
A.B. Dental Devices' implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients. Two-piece implants - 11, 12, 12b & I5: Two-stage implants - 12, 12b & 15 implants: One-stage implants - 11 One piece implants - 16, 17 Implants for immediate loading when good primary stability is achieved and with appropriate occlusal loading 12, 12b, 15, 16 & 17.

Source page: https://510kreport.com/device/K051719
Methodology: https://510kreport.com/methodology