510(k) · Cleared
ClearedAB Dental Devices Implants and Accessories
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 Apr 18, 2012 as substantially equivalent to K051719 (A.B. Dental Devices, Ltd., 2006) and 7 other predicates after a 238-day review. Its family tree reaches back 13 generations to 1996. 36 later devices descend from it.
- Decided
- Apr 18, 2012
- Review
- 238 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 13 generations to K960026 (1996). 197 ancestors in all, the oldest K820013 (1982). 36 later devices descend from it, 7 citing it directly.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 1 generation backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- This deviceK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
- Descendant · cites it directly · 25 of its ownK132125 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 · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014
- Descendant · 2 generations on · 4 of its ownK162482 A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK052419 Maximus 3.0 and OS ImplantsBioHorizons Implant Systems, Inc. · 2005
- 3 generations backK093321 Biohorizons Laser-Lok 3.0 Implant SystemBioHorizons Implant Systems, Inc. · 2010 · Recalled
- 2 generations backK100985 Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc. · 2010
- 1 generation backK103691 Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc. · 2011 · Recalled
- This deviceK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
- K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · cites it directly14descendants
- K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 2 generations on7descendants
- K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · cites it directly6descendants
- K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K052419 | Maximus 3.0 and OS Implants | BioHorizons Implant Systems, Inc. | 2005 | — |
| −3 | K093321 | Biohorizons Laser-Lok 3.0 Implant System | BioHorizons Implant Systems, Inc. | 2010 | 1 |
| −2 | K100985 | Biohorizons Simple Solutions with Laser-Lok | BioHorizons Implant Systems, Inc. | 2010 | — |
| −1 | K103691 | Biohorizons Abutments for Zimmer | BioHorizons Implant Systems, Inc. | 2011 | 1 |
| 0 (this device) | K112440 | AB Dental Devices Implants and Accessories | A.B. Dental Devices, Ltd. | 2012 | — |
| +1 | 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 | K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -… | Ditron Precision, Ltd. | 2014 | — |
| +2 | K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 12 | 0 |
| 1994 | 13 | 0 |
| 1995 | 9 | 0 |
| 1996 | 13 | 0 |
| 1997 | 5 | 0 |
| 1998 | 7 | 0 |
| 1999 | 12 | 0 |
| 2000 | 8 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 12 | 0 |
| 2004 | 13 | 0 |
| 2005 | 5 | 0 |
| 2006 | 11 | 0 |
| 2007 | 9 | 0 |
| 2008 | 8 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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? (9)
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 |
|---|---|---|---|
| * | K051719 | A.B. Dental DevicesSummary page 3…K number 12 Screw Type AB Dental 12, screw type, MIS Implant Technologies, Bie- _____________________ K051719 Cr,1000 15 Conical AB Dental, 15 Conical, K051719 M.I.S Implan… | 2006 |
| * | K040807 | Mis Dental Implant SystemSummary page 3…de anti-rotation MIS, MD-WMAC1 Wide AlfaBia, tec, TLAW, K(063364 abutment cementing post, SP, K040807 _____________ P3W - Wide anti-rotation MIS, MD-WMAC1 Wide AlfaBia, tec, TLAW, K(06… | 2004 |
| * | K080162 | Uno - One Piece Screw-Type Dental ImplantSummary page 3…AS Dental, 17 One-piece, M.IS Implant Technologies, Uno K(051719 one piece screw type, K080162 110 Trapeze Nobel Biocare, Nobel Active, ADIN, Touareg WP5inmD,… | 2008 |
| * | K102436 | Nobel Active 3.0Summary page 3…w type, K080162 110 Trapeze Nobel Biocare, Nobel Active, ADIN, Touareg WP5inmD, K(102436 K(081751 P1-Non Hexed Abutment AS Dental, P1-Non Hexed Biohorizon,… | 2010 |
| * | K081751 | Adin Dental Implants SystemSummary page 10…No AS Dental AD -Dental MIS Product Name Product Name- INumber Indication Abutment with a K081 751 for Use flat connection Abutment With a for screw flat connection for re… | 2008 |
| * | K103691 | Biohorizons Abutments for Zimmer Cleared while this submission was under review Summary page 3…Abutment, K(051719 Abutments - Non-hexed, K103691 P3 Abutment Anti-rotation AS Dental, P3 Abutment Anti- Biohorizon, Internal Laser-Lak _______… | 2011 |
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 3…64 -abutment - cementing post, SP, K(040807 ______________ P9HG-3.75,11 Gold Composed AlfaBio tec, TLABG, 1K063364 MIS, MG-GPC10 Direct gold Hex Abutment plastic cylinde… | 2007 |
| * | K042654 | Protection Plus Earloop Procedure MaskSummary page 11…i-4V-ELI. ________Grade-5+plastic. I+plastic. P5roduct R 42 Name A Number K042654 Indication Used to allow the Used to allow the for Use gingiva to heal gingiva to heal aro… | 2004 |
| * | — | MIS Implant Technologies, Bie-Cr, 1000 Named without a submission number |
What descends from it? (36)
See all 367 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132125 | A.B. Dental Devices Dental Implants System | 2014 | 25 |
| K140440 | Noris Medical Dental Implants System | 2014 | 14 |
| K140728 | Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece… | 2014 | 6 |
| K133362 | SGS Dental Implant | 2014 | 2 |
| K143326 | T.A.G. Dental Implant System | 2015 | 1 |
| K180968 | AlphaDent Implants Dental Implants System | 2019 | 0 |
| K151169 | OsteoReady ZircoSeal Abutments | 2015 | 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 16 years and passes through 2 companies; a new generation was cleared every 8 months on median.
- 27 of the 197 ancestors have a recall of any class.
- Of its descendants, K132125 (A.B. Dental Devices, Ltd., 2014) has gone furthest, with 25 descendants of its own.
- 3 other devices also cite its predicate K051719.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112440: AB Dental Devices Implants and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112440
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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