# K132125: A.B. Dental Devices Dental Implants System

- Pathway: 510(k) (Traditional)
- Applicant: A.B. Dental Devices, Ltd.
- Decided: Jan 21, 2014 after 195 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: 14 generations back to K960026 (1996). 247 ancestors in all.
25 later devices descend from it; 6 cite it directly.
0 of 273 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092555: Uno Narrow Implant, Mis Implants Technologies, Ltd. (2010) Summary page 2.
- K063364: Alpha Bio Dental Implant System, Alpha-Bio Tec, Ltd. (2007) Summary page 2.
- K031106: Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XX, Imtec Corp. (2003) Summary page 2.
- K071370: Nobelactive Internal Connection Implant, Nobel Biocare AB (2007) Summary page 2.
- K102436: Nobel Active 3.0, Nobel Biocare AB (2010) Summary page 2.
- K041876: Nobeldirect OD Implant, Nobel Biocare Uas, Inc. (2004) Summary page 2.
- K040807: Mis Dental Implant System, Mis - Implant Technologies, Ltd. (2004) Summary page 2.
- K103691: Biohorizons Abutments for Zimmer, BioHorizons Implant Systems, Inc. (2011) Summary page 2.
- K052600: Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled), Zimmer Dental, Inc. (2005) Summary page 2.
- K061847: Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452S, Zimmer Dental, Inc. (2006) Summary page 2.
- K092377: Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S, Zimmer Dental, Inc. (2009) Summary page 2.
- K051719: A.B. Dental Devices, A.B. Dental Devices, Ltd. (2006) Summary page 2.
- K112440: AB Dental Devices Implants and Accessories, A.B. Dental Devices, Ltd. (2012) Summary page 2.
- K072570: Nobelactive Multi Unit Abutment, Nobel Biocare AB (2007) Summary page 2.
- K093643: Multi- Unit Abutments for Straumann and Astra Tech Implant Systems, Nobel Biocare AB (2010) Summary page 2.
- K031719: Esthetic Zirconia Abutment, Nobel Biocare AB (2003) Summary page 2.
- K061529: Procera Zirconia Abutment for Camlog Implant System, Nobel Biocare AB (2006) Summary page 2.
- K091904: Nobelprocera ZI Abutment, Nobel Biocare AB (2009) Summary page 2.
- K061477: Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant Systems, Nobel Biocare AB (2006) Summary page 2.
- K083480: Inclusive Zirconia Abutment Blanks, Inclusive Dental Solutions (2009) Summary page 2.
- K083324: Locator Implant Anchor Attachment System, Zest Anchors, Inc. (2009) Summary page 2.
- K103089: Seven Implants; Biocom Implants; Lance Implants, Mis - Implant Technologies, Ltd. (2011) Summary page 4.

## Most influential descendants
- 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
- K162482: A.B. DENTAL DEVICES Dental Implants System (2017), 4 descendants of its own
- K183024: Implacil Implant System (2020), 2 descendants of its own
- K173343: Zygomatic Implant System (2018), 2 descendants of its own

## Indications for use
A.BDENTAL DEVICES® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. A.B. DENTAL DEVICES® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. 'Two Stage Implants: 12,15,1661. One Stage: 16, 16b, 16B. One Stage & One-Piece 3.0 mm diameter implants: 16, 168, 1681, are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants. One stage & One-Piece 2.4 mm diameter implants for temporary use or long term use: 16, 16b, permit immediate splint stability and long term fixation of new or existing crown, bridge and prosthesis. P14 Angulated Abutment Adapter is to be used with implant diameter 4.2mm and higher.

Source page: https://510kreport.com/device/K132125
Methodology: https://510kreport.com/methodology