510(k) Report

510(k) · Cleared

Cleared

Dentaurum Bracket Positioning Gauge

K935153510(k) TraditionalCleared Jan 31, 199495-day reviewClass I21 CFR 872.4565

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

Dentauraum, Inc. · ECQ Aligner, Bracket, 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.

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

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

FIG. 1 — Lineage of K935153Source: FDA 510(k) database · 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.

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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?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All ECQ devices

ECQ Aligner, Bracket, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ECQ

FDA has decided no ECQ device since 2007.

Median 510(k) review, days · ECQ

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

Recalls per year · ECQ

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · ECQ

1in 2018

2015: 12018: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code ECQ, 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—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—10
20140—00
20150—01
20160—00
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
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 ECQ

The ECQ category page

  • K851454A-Company Stainless Steel Orthodontic BracketsA Company, Inc. · 1985

https://510kreport.com/device/K935153 · printed Nov 6, 2026

Cite this page

510(k) Report. “K935153: Dentaurum Bracket Positioning Gauge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935153

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