510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Branemark System Self-Tapping Fixture

K925762510(k) TraditionalCleared Oct 12, 1993333-day reviewClass II21 CFR 872.3640Recalls 1

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 Oct 12, 1993 after a 333-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it. It has been recalled once.

Decided
Oct 12, 1993
Review
333 days
Class
Class II
Product code
DZE
Recalls
1
Predicates
0

51 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2021: 3 descendants cleared1997: 1 descendant cleared2005: 1 descendant cleared2007: 4 descendants cleared2008: 2 descendants cleared2004: 1 descendant cleared2010: 1 descendant cleared2006: 1 descendant cleared2017: 3 descendants cleared2015: 1 descendant cleared2016: 3 descendants cleared2018: 6 descendants cleared2013: 2 descendants cleared2012: 1 descendant cleared2019: 3 descendants cleared2020: 4 descendants cleared2024: 3 descendants cleared2026: 3 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared2023: 5 descendants cleared1990200020102020
  1. This deviceK925762 Branemark System Self-Tapping FixtureNobelpharma USA, Inc. · 1993
  2. Descendant · cites it directly · 50 of its ownK970499 Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997
  3. Descendant · 2 generations on · 32 of its ownK033171 Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004
  4. Descendant · 2 generations on · 31 of its ownK052490 Endosseous Dental Implant SystemNorthern Implants, LLC · 2005
  5. Descendant · 3 generations on · 24 of its ownK061169 Endosseous Dental ImplantNorthern Implants, LLC · 2006
  6. Descendant · 3 generations on · 21 of its ownK070841 Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

1997: 12004: 12005: 12006: 12007: 42008: 22010: 12012: 12013: 22015: 12016: 32017: 32018: 62019: 32020: 42021: 32022: 22023: 52024: 32025: 12026: 3
1997high 6 (2018) · low 0 (1998)2026

Most influential descendants

Showing 5 of 51 · See all
  • K970499Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc. · 1997 · cites it directly50descendants
  • K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC · 2004 · 2 generations on32descendants
  • K052490Endosseous Dental Implant SystemNorthern Implants, LLC · 2005 · 2 generations on31descendants
  • K061169Endosseous Dental ImplantNorthern Implants, LLC · 2006 · 3 generations on24descendants
  • K070841Endosseous Dental Implant SystemSouthern Implants, Inc. · 2007 · 3 generations on21descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925762Branemark System Self-Tapping FixtureNobelpharma USA, Inc.1993—
+1K970499Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc.1997—
+2K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC2004—
+2K052490Endosseous Dental Implant SystemNorthern Implants, LLC2005—
+3K061169Endosseous Dental ImplantNorthern Implants, LLC2006—
+3K070841Endosseous Dental Implant SystemSouthern Implants, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200410
200510
200610
200740
200820
201010
201210
201320
201510
201630
201730
201860
201930
202040
202130
202220
202350
202430
202510
202630
FIG. 1 — Lineage of K925762, 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (51)

See all 51

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

NumberDeviceApplicantDecidedDescendants
K970499Branemark System Zygomaticus Fixture SystemNobel Biocare Uas, Inc.199750
K192839DSP Implant SystemD.S.P Industrial Eireli20210

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 9, 2019Class IIZ-1856-2020Process controlPackages of abutments (universal base) may contain an incorrect screw. While the screw will tighten, it cannot be guaranteed that the screw will not loosen. In case the screw loosens the abutment should be retightened with the correct…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K970499 (Nobel Biocare Uas, Inc., 1997) has gone furthest, with 50 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—

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

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/K925762 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925762: Branemark System Self-Tapping Fixture.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925762

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026