510(k) Report

510(k) · Cleared

Cleared

A.B. Dental Devices

K051719510(k) TraditionalCleared Mar 21, 2006267-day reviewClass II21 CFR 872.3640

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

A.B. Dental Devices, Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on Mar 21, 2006 after a 267-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 37 later devices descend from it.

Decided
Mar 21, 2006
Review
267 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

37 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 2 descendants cleared2014: 4 descendants cleared2019: 4 descendants cleared2016: 3 descendants cleared2017: 1 descendant cleared2022: 4 descendants cleared2020: 3 descendants cleared2024: 5 descendants cleared2021: 3 descendants cleared2018: 2 descendants cleared2026: 4 descendants cleared2025: 1 descendant cleared20052010201520202025
  1. This deviceK051719 A.B. Dental DevicesA.B. Dental Devices, Ltd. · 2006
  2. Descendant · cites it directly · 36 of its ownK112440 AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012
  3. Descendant · cites it directly · 25 of its ownK132125 A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
  4. Descendant · 2 generations on · 14 of its ownK140440 Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014
  5. Descendant · 3 generations on · 7 of its ownK151909 Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016
  6. Descendant · 2 generations on · 6 of its ownK140728 Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision…Ditron Precision, Ltd. · 2014

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2012: 12014: 42015: 22016: 32017: 12018: 22019: 42020: 32021: 32022: 42024: 52025: 12026: 4
2012high 5 (2024) · low 0 (2013)2026

Most influential descendants

Showing 5 of 37 · See all
  • K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012 · cites it directly36descendants
  • K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014 · cites it directly25descendants
  • K140440Noris Medical Dental Implants SystemNoris Medical, Ltd. · 2014 · 2 generations on14descendants
  • K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd. · 2016 · 3 generations on7descendants
  • K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd. · 2014 · 2 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K051719A.B. Dental DevicesA.B. Dental Devices, Ltd.2006—
+1K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.2012—
+1K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.2014—
+2K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.2014—
+3K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.2016—
+2K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi -…Ditron Precision, Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201440
201520
201630
201710
201820
201940
202030
202130
202240
202450
202510
202640
FIG. 1 — Lineage of K051719, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (37)

See all 37

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236
K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425
K133362SGS Dental ImplantSgs International, Ltd.20142
K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150

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?

  • Of its descendants, K112440 (A.B. Dental Devices, Ltd., 2012) has gone furthest, with 36 descendants of its own.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

More from A.B. Dental Devices, Ltd.

4 FDA decisions under this applicant name. See the company

  • K250806Dental Implant SystemA.B. Dental Devices, Ltd. · 2026
  • K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd. · 2014
  • K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd. · 2012

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K051719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051719: A.B. Dental Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051719

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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