510(k) Report

510(k) · Cleared

Cleared

Memory Wire

K923372510(k) TraditionalCleared Apr 22, 1994652-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

Althan, Inc. · EJF Bracket, Metal, Orthodontic

Cleared on Apr 22, 1994 after a 652-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 22, 1994
Review
652 days
Class
Class I
Product code
EJF
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 K923372Source: 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.

Planning a device in EJF? 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?

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 EJF devices

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

FDA decisions per year · EJF

FDA has decided no EJF device since 2007.

Median 510(k) review, days · EJF

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

Recalls per year · EJF

1in 2013

2009: 12012: 12013: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · EJF

3in 2025

2007: 22008: 72009: 192010: 182011: 122012: 52013: 72014: 82015: 92016: 52017: 82018: 32019: 12020: 42021: 12022: 72023: 62024: 22025: 3
2007high 19 (2009) · low 1 (2019)2025

MAUDE reports naming product code EJF, 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—02
20080—07
20090—119
20100—018
20110—012
20120—15
20130—17
20140—08
20150—09
20160—05
20170—08
20180—03
20190—01
20200—04
20210—01
20220—07
20230—06
20240—02
20250—03
20260—0—

Recent decisions in EJF

The EJF category page

  • K994357Bitem Lock, Models SW006, SW012Thermoelastic Technologies, Inc. · 2000
  • K932825Microarch Gold BracketGac Intl., Inc. · 1994
  • K933501AlastikUnitek Corp. · 1994
  • K933080Orthotech Dura-Gold BarcketsOrthotech · 1994
  • K935139Fascination Ceramic BracketDentauraum, Inc. · 1994

https://510kreport.com/device/K923372 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923372: Memory Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923372

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