510(k) Report

510(k) · Cleared

Cleared

Onplant Orthodontic System

K980460510(k) TraditionalCleared May 5, 199892-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

Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on May 5, 1998 as substantially equivalent to K925776 (Nobelpharma USA, Inc., 1994) and 5 other predicates after a 92-day review. Its family tree reaches back 1 generation to 1993. 80 later devices descend from it.

Decided
May 5, 1998
Review
92 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K925771 (1993). 6 ancestors in all. 80 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1994: 2 other ancestors1993: 2 other ancestors1998: 1 descendant cleared2004: 7 descendants cleared2024: 4 descendants cleared2007: 5 descendants cleared2006: 10 descendants cleared2009: 5 descendants cleared2005: 5 descendants cleared2008: 6 descendants cleared2012: 2 descendants cleared2011: 5 descendants cleared2013: 2 descendants cleared2010: 2 descendants cleared2018: 2 descendants cleared2026: 2 descendants cleared2019: 4 descendants cleared2015: 2 descendants cleared2020: 4 descendants cleared2016: 2 descendants cleared2021: 4 descendants cleared2017: 2 descendants cleared2023: 1 descendant cleared2025: 2 descendants cleared2022: 1 descendant clearedK925771 · Branemark System Titanium Cover Screws · Nobelpharma USA, Inc. · 19931990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 3 descendants2 generations forward: 14 descendants3 generations forward: 24 descendants4 generations forward: 16 descendants5 generations forward: 8 descendants6 generations forward: 8 descendants7 generations forward: 4 descendants8 generations forward: 3 descendants K925771 · Branemark System Titanium Cover Screws · Nobelpharma USA, Inc. · 19930+5
  1. Root · 1 generation backK925771 Branemark System Titanium Cover ScrewsNobelpharma USA, Inc. · 1993
  2. This deviceK980460 Onplant Orthodontic SystemNobel Biocare Uas, Inc. · 1998
  3. Descendant · cites it directly · 66 of its ownK982509 Ortho Implant and AccessoriesStraumann USA · 1998
  4. Descendant · 2 generations on · 63 of its ownK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
  5. Descendant · 2 generations on · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
  6. Descendant · 2 generations on · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005
  7. Descendant · 3 generations on · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

1998: 12004: 72005: 52006: 102007: 52008: 62009: 52010: 22011: 52012: 22013: 22015: 22016: 22017: 22018: 22019: 42020: 42021: 42022: 12023: 12024: 42025: 22026: 2
1998high 10 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 80 · See all
  • K982509Ortho Implant and AccessoriesStraumann USA · 1998 · cites it directly66descendants
  • K031936Osteomed Orthodontic Screw SystemOsteomed LP · 2004 · 2 generations on63descendants
  • K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · 2 generations on54descendants
  • K042965Tomas PinDentaurum, Inc. · 2005 · 2 generations on26descendants
  • K060126Absoanchor MicroimplantDentos, Inc. · 2006 · 3 generations on19descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K925771Branemark System Titanium Cover ScrewsNobelpharma USA, Inc.1993—
0 (this device)K980460Onplant Orthodontic SystemNobel Biocare Uas, Inc.1998—
+1K982509Ortho Implant and AccessoriesStraumann USA1998—
+2K031936Osteomed Orthodontic Screw SystemOsteomed LP2004—
+2K033767Dual Top Anchor System ScrewsJeil Medical Corporation2004—
+2K042965Tomas PinDentaurum, Inc.2005—
+3K060126Absoanchor MicroimplantDentos, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199320
199420
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200470
200550
2006100
200750
200860
200950
201020
201150
201220
201320
201520
201620
201720
201820
201940
202040
202140
202210
202310
202440
202520
202620
FIG. 1 — Lineage of K980460, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #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? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K925776Branemark System Interlocking Abutment/Gold Cylind
Summary page 1
…c System. C. The Predicate Product The predicate products used in this Pre-market Notification are other components marketed by Nobel Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K…
Nobelpharma USA, Inc.1994—
*K925771Branemark System Titanium Cover Screws
Summary page 1
…n this Pre-market Notification are other components marketed by Nobel Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Li…
Nobelpharma USA, Inc.1993—
*K944964Branemark System Miruscone Abutment System
Summary page 1
…n are other components marketed by Nobel Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Linkow Blade Implant, which is…
Nobelpharma USA, Inc.1995—
*K925774Branemark System Hand Instrument
Summary page 1
…ed by Nobel Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Linkow Blade Implant, which is marketed by Steri-Oss, and Or…
Nobelpharma USA, Inc.1993—
*K925772Branemark System Guide Pins
Summary page 1
…Biocare including the Cylinders, (K925776), Abutments and Abutment Screws (K925776), Cover Screws, (K925771),. Abutment Replica (K944964), Hand Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Linkow Blade Implant, which is marketed by Steri-Oss, and Orthodontic Wi…
Nobelpharma USA, Inc.1993—
*K935142Dentaurum Wires
Summary page 1
…nd Instruments, (K925774 and K925772) as well as other orthodontic anchor devices such as the Linkow Blade Implant, which is marketed by Steri-Oss, and Orthodontic Wire (K935142) marketed by Dentaurum, and pre-amendment orthodontic wire marketed by Star Dental. D. Description of the Device The Nobel Bioc…
Dentauraum, Inc.1994—
*—Linkow Blade Implant
Named without a submission number
—
*—Pre-amendment orthodontic wire
Named without a submission number
—

What descends from it? (80)

See all 80

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

NumberDeviceApplicantDecidedDescendants
K982509Ortho Implant and AccessoriesStraumann USA199866
K033483KLS-Martin Ortho Anchorage SystemKLS-Martin L.P.200418
K040891KLS Martin Ortho Anchorage System (Plates)KLS-Martin L.P.20047

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?

  • None of the 6 ancestors has a recall.
  • Of its descendants, K982509 (Straumann USA, 1998) has gone furthest, with 66 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?

The Nobel Biocare Onplant Orthodontic System is an implant intended to be surgically placed

subperiosteal in the palatal region of the mouth for use as an anchor for orthodontic procedures in patients

who have completed skeletal growth and maturity.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Nobel Biocare Uas, Inc.

31 FDA decisions under this applicant name. See the company

  • K050444Nobelreplace Adapter, Model 32412Nobel Biocare Uas, Inc. · 2005
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004
  • K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
  • K041876Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004
  • K041312Nobelrondo Dental Ceramic-AluminaNobel Biocare Uas, Inc. · 2004

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/K980460 · printed Nov 3, 2026

Cite this page

510(k) Report. “K980460: Onplant Orthodontic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K980460

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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