510(k) · Cleared
ClearedA.B. Dental Devices Dental Implants System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A.B. Dental Devices, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 21, 2014 as substantially equivalent to K092555 (Mis Implants Technologies, Ltd., 2010) and 21 other predicates after a 195-day review. Its family tree reaches back 14 generations to 1996. 25 later devices descend from it.
- Decided
- Jan 21, 2014
- Review
- 195 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 22
Its longest line of descent runs back 14 generations to K960026 (1996). 247 ancestors in all, the oldest K781060 (1978). 25 later devices descend from it, 6 citing it directly.
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations between
- 3 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 2 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 1 generation backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- This deviceK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
- Descendant · cites it directly · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
- Descendant · 2 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
- Descendant · cites it directly · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
- Descendant · 3 generations on · 2 of its ownK173343 Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018
Show all 14 generations
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 12 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 11 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 7 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 6 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 5 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 4 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 3 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 2 generations backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- 1 generation backK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- This deviceK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
2014high 4 (2019) · low 0 (2015)2026
Most influential descendants
Showing 5 of 25 · See all- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · cites it directly14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 2 generations on7descendants
- K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · cites it directly4descendants
- K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
- K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd. · 2018 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −13 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −7 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −6 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −5 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −4 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −3 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −2 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| −1 | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| 0 (this device) | K132125 | A.B. Dental Devices Dental Implants System | A.B. Dental Devices, Ltd. | 2014 | — |
| +1 | K140440 | Noris Medical Dental Implants System | Noris Medical, Ltd. | 2014 | — |
| +2 | K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical, Ltd. | 2016 | — |
| +1 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | 2017 | — |
| +2 | K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | 2020 | — |
| +3 | K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 11 | 0 |
| 1996 | 14 | 0 |
| 1997 | 6 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 15 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 16 | 0 |
| 2007 | 14 | 0 |
| 2008 | 9 | 0 |
| 2009 | 9 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (22)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K092555 | Uno Narrow ImplantSummary page 2…ssion : New Device 8 Identification of Legally Marketed Predicate Devices: A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use,… | 2010 |
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 2…Identification of Legally Marketed Predicate Devices: A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use, technological char… | 2007 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 2…on of Legally Marketed Predicate Devices: A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use, technological characteristics, pe… | 2003 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…Predicate Devices: A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use, technological characteristics, performance and user inte… | 2007 |
| * | K102436 | Nobel Active 3.0Summary page 2…ices: A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use, technological characteristics, performance and user interface. A.… | 2010 |
| * | K041876 | Nobeldirect OD ImplantSummary page 2…A.B. DENTAL DEVICES@® Dental Implants System is substantially equivalent to M.IS, K092555; Alpha Bio Tec K063364; IMTEC K031106; Nobel Biocare K071370, K102436, K041876; in terms of intended use, indication for use, technological characteristics, performance and user interface. A.B. DENTAL… | 2004 |
| * | K040807 | Mis Dental Implant SystemSummary page 2…on for use, technological characteristics, performance and user interface. A.B. DENTAL DEVICES@® Dental Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Bioc… | 2004 |
| * | K103691 | Biohorizons Abutments for ZimmerSummary page 2…gical characteristics, performance and user interface. A.B. DENTAL DEVICES@® Dental Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093… | 2011 |
| * | K052600 | Zimmer Dental Hex-Lock Prepared Abutment (Straight & Angled)Summary page 2…and user interface. A.B. DENTAL DEVICES@® Dental Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477… | 2005 |
| * | K061847 | Zimmer Contour Ceramic Abutment, Models ZRA341S, ZRA342S, KRA451S, ZRA452SSummary page 2…rface. A.B. DENTAL DEVICES@® Dental Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive d… | 2006 |
| * | K092377 | Plastic Temporary Abutments, Models: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S…Summary page 2…A.B. DENTAL DEVICES@® Dental Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental sol… | 2009 |
| * | K051719 | A.B. Dental DevicesSummary page 2…al Abutments System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Ancho… | 2006 |
| * | K112440 | AB Dental Devices Implants and AccessoriesSummary page 2…nts System is substantially equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K08332… | 2012 |
| * | K072570 | Nobelactive Multi Unit AbutmentSummary page 2…equivalent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use… | 2007 |
| * | K093643 | Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsSummary page 2…ent to M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indica… | 2010 |
| * | K031719 | Esthetic Zirconia AbutmentSummary page 2…M.IS. K040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for… | 2003 |
| * | K061529 | Procera Zirconia Abutment for Camlog Implant SystemSummary page 2…040807; Biohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, te… | 2006 |
| * | K091904 | Nobelprocera ZI AbutmentSummary page 2…iohorizon K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, technologic… | 2009 |
| * | K061477 | Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsSummary page 2…K103691; Alpha Bio Tec K063364; Zimmer K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, technological charac… | 2006 |
| * | K083480 | Inclusive Zirconia Abutment BlanksSummary page 2…r K052600, K061847, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, technological characteristics, performance and user interf… | 2009 |
| * | K083324 | Locator Implant Anchor Attachment SystemSummary page 2…, K092377; A.B.Dental Devices K051719, K112440; Nobel Biocare K072570,K093643, K031719, K061529, K091904, K061477; Inclusive dental solutions K083480; Zest Anchors K083324; in terms of intended use, indication for use, technological characteristics, performance and user interface. The predicate d… | 2009 |
| * | K103089 | Seven Implants; Biocom Implants; Lance ImplantsSummary page 4…fat- Sand Blast &Acid Etched Hydroxyapatite A.B. Dental Devices NobelBiocare K103089 Product Name I5 - Conical Implant Nobel Active Material OR-s Titanium Ti-6A1-… | 2011 |
What descends from it? (25)
See all 256 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140440 | Noris Medical Dental Implants System | 2014 | 14 |
| K162482 | A.B. DENTAL DEVICES Dental Implants System | 2017 | 4 |
| K133362 | SGS Dental Implant | 2014 | 2 |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | 2019 | 0 |
| K180968 | AlphaDent Implants Dental Implants System | 2019 | 0 |
| K152555 | Dental Implant System | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 33 of the 247 ancestors have a recall of any class.
- Of its descendants, K140440 (Noris Medical, Ltd., 2014) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K092555.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2007high 61 (2008) · low 26 (2011)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
2007high 265 (2014) · low 107 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
2007high 15 (2016) · low 0 (2011)2026
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
2007high 537,585 (2023) · low 164 (2009)2025
MAUDE reports naming product code DZE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
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…
Read the full statement (157 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132125: A.B. Dental Devices Dental Implants System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132125
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026