510(k) Report

510(k) · Cleared

Cleared

Dentaurum Wires

K935142510(k) TraditionalCleared Jan 31, 199495-day reviewClass I21 CFR 872.5410

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

Dentauraum, Inc. · DZC Wire, Orthodontic

Cleared on Jan 31, 1994 after a 95-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 81 later devices descend from it.

Decided
Jan 31, 1994
Review
95 days
Class
Class I
Product code
DZC
Recalls
None
Predicates
0

81 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 2 descendants 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 cleared1990200020102020
  1. This deviceK935142 Dentaurum WiresDentauraum, Inc. · 1994
  2. Descendant · cites it directly · 80 of its ownK980460 Onplant Orthodontic SystemNobel Biocare Uas, Inc. · 1998
  3. Descendant · 2 generations on · 66 of its ownK982509 Ortho Implant and AccessoriesStraumann USA · 1998
  4. Descendant · 3 generations on · 63 of its ownK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
  5. Descendant · 3 generations on · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
  6. Descendant · 3 generations on · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005

Showing 5 of 81 descendants. See all descendants

Descendants cleared per year

1998: 22004: 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 81 · See all
  • K980460Onplant Orthodontic SystemNobel Biocare Uas, Inc. · 1998 · cites it directly80descendants
  • K982509Ortho Implant and AccessoriesStraumann USA · 1998 · 2 generations on66descendants
  • K031936Osteomed Orthodontic Screw SystemOsteomed LP · 2004 · 3 generations on63descendants
  • K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · 3 generations on54descendants
  • K042965Tomas PinDentaurum, Inc. · 2005 · 3 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935142Dentaurum WiresDentauraum, Inc.1994—
+1K980460Onplant Orthodontic SystemNobel Biocare Uas, Inc.1998—
+2K982509Ortho Implant and AccessoriesStraumann USA1998—
+3K031936Osteomed Orthodontic Screw SystemOsteomed LP2004—
+3K033767Dual Top Anchor System ScrewsJeil Medical Corporation2004—
+3K042965Tomas PinDentaurum, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
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 K935142, 1994–2026Source: 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 DZC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (81)

See all 81

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K980460Onplant Orthodontic SystemNobel Biocare Uas, Inc.199880

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, K980460 (Nobel Biocare Uas, Inc., 1998) has gone furthest, with 80 descendants of its own.

How does its category compare?

All DZC devices

DZC Wire, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZC

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZC

Too few DZC 510(k)s in any year since 2007 to give a median.

Recalls per year · DZC

1in 2015

2011: 12013: 22015: 1
2007high 2 (2013) · low 0 (2007)2026

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

Adverse event reports per year · DZC

1in 2025

2007: 332008: 1432009: 342010: 12012: 12013: 52014: 12015: 22016: 42017: 12018: 22019: 62020: 12021: 32022: 72023: 22024: 12025: 1
2007high 143 (2008) · low 0 (2011)2025

MAUDE reports naming product code DZC, 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
20070—033
20080—0143
20090—034
20100—01
20111—10
20120—01
20130—25
20140—01
20150—12
20160—04
20170—01
20180—02
20190—06
20200—01
20210—03
20220—07
20230—02
20240—01
20250—01
20260—0—

More from Dentauraum, Inc.

24 FDA decisions under this applicant name. See the company

  • K952866Rematitan TitaniumDentauraum, Inc. · 1995
  • K952870Remanium: CS & G-SoftDentauraum, Inc. · 1995
  • K952867Remanium:GM 700, GM 380, GM 800, GFHDentauraum, Inc. · 1995
  • K952865Remanium: 200,CS, 380, and CDDentauraum, Inc. · 1995
  • K952868Dentaurum Jacket Crown & Root PostsDentauraum, Inc. · 1995

Recent decisions in DZC

The DZC category page

  • K112640Hyperelastic WireOrmco Corp. · 2011
  • K943334Hawley Retainer Orthodontic Applicance KitJay H. Geller · 1994
  • K935638Nitinol, NitiHighland Metals · 1994
  • K935140Dentaurum Steel Ligature WiresDentauraum, Inc. · 1994
  • K934265Flexmedics Super-Seven Stranded Nickel-Titanium ArchwireFlexmedics · 1994

https://510kreport.com/device/K935142 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935142: Dentaurum Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935142

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