510(k) Report

510(k) · Cleared

Cleared

Branemark System Abutments Complete

K925769510(k) TraditionalCleared Apr 14, 1993149-day reviewClass II21 CFR 872.3630

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

Nobelpharma USA, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Apr 14, 1993 after a 149-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 568 later devices descend from it.

Decided
Apr 14, 1993
Review
149 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

568 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2010: 10 descendants cleared2002: 1 descendant cleared2006: 10 descendants cleared2005: 5 descendants cleared2004: 7 descendants cleared2017: 26 descendants cleared2007: 8 descendants cleared2016: 34 descendants cleared2015: 28 descendants cleared2009: 15 descendants cleared2014: 21 descendants cleared2011: 15 descendants cleared1998: 1 descendant cleared2008: 9 descendants cleared2013: 16 descendants cleared2018: 27 descendants cleared2012: 14 descendants cleared2019: 25 descendants cleared2020: 43 descendants cleared2022: 37 descendants cleared2024: 61 descendants cleared2021: 39 descendants cleared2023: 45 descendants cleared2026: 26 descendants cleared2025: 43 descendants cleared1990200020102020
  1. This deviceK925769 Branemark System Abutments CompleteNobelpharma USA, Inc. · 1993
  2. Descendant · cites it directly · 545 of its ownK971706 Tiadapt Abutment SystemNobel Biocare Uas, Inc. · 1997
  3. Descendant · 2 generations on · 543 of its ownK974150 Procera Preparable Abutment SystemNobel Biocare Uas, Inc. · 1998 · Recalled
  4. Descendant · 3 generations on · 476 of its ownK032263 3I Patient-Specific Dental Abutment and Overdenture BarImplant Innovations, Inc. · 2004 · Recalled
  5. Descendant · 3 generations on · 441 of its ownK042658 Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001…Nobel Biocare Uas, Inc. · 2004
  6. 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 568 descendants. See all descendants

Descendants cleared per year

1997: 21998: 12002: 12004: 72005: 52006: 102007: 82008: 92009: 152010: 102011: 152012: 142013: 162014: 212015: 282016: 342017: 262018: 272019: 252020: 432021: 392022: 372023: 452024: 612025: 432026: 26
1997high 61 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 568 · 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
0 (this device)K925769Branemark System Abutments CompleteNobelpharma USA, Inc.1993—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
199810
200210
200470
200550
2006100
200780
200890
2009150
2010100
2011150
2012140
2013160
2014210
2015280
2016340
2017260
2018270
2019250
2020430
2021390
2022370
2023450
2024610
2025430
2026260
FIG. 1 — Lineage of K925769, 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 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 NHA? 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 NHA device

  1. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 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? (568)

See all 568

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

NumberDeviceApplicantDecidedDescendants
K971706Tiadapt Abutment SystemNobel Biocare Uas, Inc.1997545
K061477Multi-Unit Abutments for Astratech, Camlog and Ankylos Implant SystemsNobel Biocare AB200666
K020617Nsi Hexed and Non-Hexed Implant SystemNsi200236
K972475Auradapt Aubtment SystemNobel Biocare Uas, Inc.19972
K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100

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, K971706 (Nobel Biocare Uas, Inc., 1997) has gone furthest, with 545 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

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
  • K962403Noblepharma Wide AccessoriesNobelpharma USA, Inc. · 1996
  • K955713Nobelpharma Bone Anchored Hearing AidNobelpharma USA, Inc. · 1996
  • K962130Branemark Systems Mkii Selk-Tapping FixtureNobelpharma USA, Inc. · 1996
  • K96173617 Angulated AbutmentNobelpharma USA, Inc. · 1996

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The NHA category page

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  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
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https://510kreport.com/device/K925769 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925769: Branemark System Abutments Complete.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925769

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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