510(k) Report

510(k) · Cleared

Cleared

Noblepharma Wide Accessories

K962403510(k) TraditionalCleared Sep 6, 199677-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

Nobelpharma USA, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 6, 1996 as substantially equivalent to K925770 (Nobelpharma USA, Inc., 1993) and 7 other predicates after a 77-day review. Its family tree reaches back 2 generations to 1995. 549 later devices descend from it.

Decided
Sep 6, 1996
Review
77 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
8

Its longest line of descent runs back 2 generations to K944964 (1995). 10 ancestors in all, the oldest K910611 (1991). 549 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1993: 6 other ancestors1991: 1 other ancestor1997: 2 descendants cleared2006: 7 descendants cleared2004: 6 descendants cleared2005: 4 descendants cleared1998: 1 descendant cleared2008: 7 descendants cleared2015: 27 descendants cleared2013: 15 descendants cleared2009: 14 descendants cleared2007: 5 descendants cleared2016: 33 descendants cleared2011: 15 descendants cleared2014: 21 descendants cleared2010: 9 descendants cleared2012: 14 descendants cleared2018: 27 descendants cleared2020: 42 descendants cleared2023: 45 descendants cleared2017: 26 descendants cleared2024: 60 descendants cleared2019: 24 descendants cleared2025: 43 descendants cleared2021: 39 descendants cleared2022: 37 descendants cleared2026: 26 descendants clearedK944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 1995K961728 · Miruscone Abutment System · Nobelpharma USA, Inc. · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 15 descendants4 generations forward: 30 descendants5 generations forward: 66 descendants6 generations forward: 104 descendants7 generations forward: 93 descendants8 generations forward: 76 descendants9 generations forward: 54 descendants10 generations forward: 37 descendants11 generations forward: 27 descendants12 generations forward: 25 descendants13 generations forward: 8 descendants14 generations forward: 4 descendants15 generations forward: 1 descendant16 generations forward: 1 descendant K961728 · Miruscone Abutment System · Nobelpharma USA, Inc. · 1996K944964 · Branemark System Miruscone Abutment System · Nobelpharma USA, Inc. · 19950+5+10+15
  1. Root · 2 generations backK944964 Branemark System Miruscone Abutment SystemNobelpharma USA, Inc. · 1995
  2. 1 generation backK961728 Miruscone Abutment SystemNobelpharma USA, Inc. · 1996
  3. This deviceK962403 Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  4. Descendant · cites it directly · 545 of its ownK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  5. Descendant · 2 generations on · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  6. Descendant · 3 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  7. Descendant · 3 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  8. Descendant · 4 generations on · 327 of its ownK043042 Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004

Showing 5 of 549 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12004: 62005: 42006: 72007: 52008: 72009: 142010: 92011: 152012: 142013: 152014: 212015: 272016: 332017: 262018: 272019: 242020: 422021: 392022: 372023: 452024: 602025: 432026: 26
1997high 60 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 549 · See all
  • K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997 · cites it directly545descendants
  • K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · 2 generations on543descendants
  • K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · 3 generations on476descendants
  • K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc. · 2004 · 3 generations on441descendants
  • K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB · 2004 · 4 generations on327descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K944964Branemark System Miruscone Abutment SystemNobelpharma USA, Inc.1995—
−1K961728Miruscone Abutment SystemNobelpharma USA, Inc.1996—
0 (this device)K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc.1996—
+1K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997—
+2K974150Procera Preparable Abutment SystemNobel Biocare Uas, Inc.19982
+3K0322633I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc.20041
+3K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004…Nobel Biocare Uas, Inc.2004—
+4K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199360
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200460
200540
200670
200750
200870
2009140
201090
2011150
2012140
2013150
2014210
2015270
2016330
2017260
2018270
2019240
2020420
2021390
2022370
2023450
2024600
2025430
2026260
FIG. 1 — Lineage of K962403, 1995–2026Source: 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
*K925770Branemark System Drills and Countersinks
Summary page 1
…CeraOne system. C. The Predicate Product The predicate products used in this Premarket Notification are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775…
Nobelpharma USA, Inc.1993—
*K925768Branemark System Screw Tap
Summary page 1
…The Predicate Product The predicate products used in this Premarket Notification are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to…
Nobelpharma USA, Inc.1993—
*K925774Branemark System Hand Instrument
Summary page 1
…predicate products used in this Premarket Notification are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and C…
Nobelpharma USA, Inc.1993—
*K925779Branemark System Titanium Healing Abutments
Summary page 1
…his Premarket Notification are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 systen. D. D…
Nobelpharma USA, Inc.1993—
*K925771Branemark System Titanium Cover Screws
Summary page 1
…ion are other components marketed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 systen. D. Description of the Devic…
Nobelpharma USA, Inc.1993—
*K925775Branemark System Machine Inst. Acc. to Drilling EQ
Summary page 1
…ed by Nobelpharma including the Drills, K925770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 systen. D. Description of the Device The Nobelpharma BRANEMARK SY…
Nobelpharma USA, Inc.1993—
*K961728Miruscone Abutment System
Cleared while this submission was under review
Summary page 1
…25770, Screw Taps, K925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 systen. D. Description of the Device The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are com…
Nobelpharma USA, Inc.1996—
*K961737Cera One Abutment System
Cleared while this submission was under review
Summary page 1
…925768, Hand Instruments, K925774, Healing Abutments, K925779, Cover Screws, K925771, Machine Instruments, K925775, and accessories to the MirusCone K961728 and CeraOne K961737 systen. D. Description of the Device The Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are components used with va…
Nobelpharma USA, Inc.1996—

Also cleared against K925770: 1 other device →

What descends from it? (549)

See all 549

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

NumberDeviceApplicantDecidedDescendants
K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997545
K972475Auradapt Aubtment SystemNobel Biocare Uas, Inc.19972

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 1 year and passes through 1 company; a new generation was cleared every 1.4 years on median.
  • None of the 10 ancestors has a recall.
  • Of its descendants, K971706 (Nobel Biocare Uas, Inc., 1997) has gone furthest, with 545 descendants of its own.
  • 1 other device also cites its predicate K925770.

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 Nobelpharma BRANEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.

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

Also cleared against K925770

1 other device cites the same predicate.

  • K970499Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997

More from Nobelpharma USA, Inc.

64 FDA decisions under this applicant name. See the company

  • K984162Branemark Bone-Anchored Hearing Aid (Baha) System for Pediatric UseNobelpharma USA, Inc. · 1999
  • K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
  • K962130Branemark Systems Mkii Selk-Tapping FixtureNobelpharma USA, Inc. · 1996
  • K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996
  • K961728Miruscone Abutment SystemNobelpharma USA, Inc. · 1996

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/K962403 · printed Nov 6, 2026

Cite this page

510(k) Report. “K962403: Noblepharma Wide Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962403

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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