510(k) Report

510(k) · Cleared

Cleared

Dentaurum Expansion Screws

K935154510(k) TraditionalCleared Feb 3, 199498-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. · DYJ Retainer, Screw Expansion, Orthodontic

Cleared on Feb 3, 1994 after a 98-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Feb 3, 1994
Review
98 days
Class
Class I
Product code
DYJ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2023: 1 descendant cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK935154 Dentaurum Expansion ScrewsDentauraum, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK232887 Invisalign Palatal Expander SystemAlign Technology, Inc. · 2023
  3. Descendant · 2 generations on · 0 of its ownK252931 Invisalign® Palatal Expander SystemAlign Technology, Inc. · 2025

Most influential descendants

Showing 2 of 2 · See all
  • K232887Invisalign Palatal Expander SystemAlign Technology, Inc. · 2023 · cites it directly1descendant
  • K252931Invisalign® Palatal Expander SystemAlign Technology, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K935154Dentaurum Expansion ScrewsDentauraum, Inc.1994—
+1K232887Invisalign Palatal Expander SystemAlign Technology, Inc.2023—
+2K252931Invisalign® Palatal Expander SystemAlign Technology, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202310
202510
FIG. 1 — Lineage of K935154, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 DYJ? 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
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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? (2)

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

NumberDeviceApplicantDecidedDescendants
K232887Invisalign Palatal Expander SystemAlign Technology, Inc.20231

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, K232887 (Align Technology, Inc., 2023) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DYJ devices

DYJ Retainer, Screw Expansion, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYJ

FDA has decided no DYJ device since 2007.

Median 510(k) review, days · DYJ

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

Recalls per year · DYJ

3in 2022

2009: 12022: 3
2007high 3 (2022) · low 0 (2007)2026

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

Adverse event reports per year · DYJ

1in 2025

2007: 62008: 32009: 22010: 12011: 42012: 32014: 12015: 22016: 22017: 22018: 122019: 92020: 32021: 62022: 52023: 112024: 32025: 1
2007high 12 (2018) · low 0 (2013)2025

MAUDE reports naming product code DYJ, 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—06
20080—03
20090—12
20100—01
20110—04
20120—03
20130—00
20140—01
20150—02
20160—02
20170—02
20180—012
20190—09
20200—03
20210—06
20220—35
20230—011
20240—03
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 DYJ

The DYJ category page

  • K970930Bilateral Infant Cleft Palate Orthodontic ApplianceCleft Palate Appliances, Inc. · 1997
  • K925088Expansion ScrewsForestadent · 1993
  • K912417Molar Distalizing AssemblyAmerican Orthodontics · 1991
  • K843705Mandibulator Jaw PositionerA Company, Inc. · 1984

https://510kreport.com/device/K935154 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935154: Dentaurum Expansion Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935154

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