# K112440: AB Dental Devices Implants and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Devices, Ltd.
- Decided: Apr 18, 2012 after 238 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: 13 generations back to K960026 (1996). 197 ancestors in all.
36 later devices descend from it; 7 cite it directly.
0 of 234 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051719: A.B. Dental Devices, A.B. Dental Devices, Ltd. (2006) Summary page 3.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 3.
- K080162: Uno - One Piece Screw-Type Dental Implant, Mis Implants Technologies, Ltd. (2008) Summary page 3.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 3.
- K081751: Adin Dental Implants System, Adin Dental Implants System, Ltd. (2008) Summary page 10.
- K103691: Biohorizons Abutments for Zimmer, BioHorizons Implant Systems, Inc. (2011). Cleared while this submission was under review Summary page 3.
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 3.
- K042654: Protection Plus Earloop Procedure Mask, Safety-Med Products, Inc. (2004) Summary page 11.
- (no number) MIS Implant Technologies, Bie-Cr, 1000: named in the summary without a submission number

## Most influential descendants
- 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
- K162482: A.B. DENTAL DEVICES Dental Implants System (2017), 4 descendants of its own

## Indications for use
The AB 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. 17 Integral implant, 15 Conical implant, P15 Temporary abutment, P12-T,L Temporary flat connection abutment, and P16 Straight adaptor are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K112440
Methodology: https://510kreport.com/methodology