510(k) Report

510(k) · Cleared

Cleared

Alastik NS

K923999510(k) TraditionalCleared Jun 24, 1993318-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

Unitek Corp. · ECI Band, Elastic, Orthodontic

Cleared on Jun 24, 1993 after a 318-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jun 24, 1993
Review
318 days
Class
Class I
Product code
ECI
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 K923999Source: 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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  • 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 ECI devices

ECI Band, Elastic, Orthodontic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ECI

FDA has decided no ECI device since 2007.

Median 510(k) review, days · ECI

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

Recalls per year · ECI

1in 2023

2011: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · ECI

1in 2024

2007: 12012: 12014: 22015: 12016: 12017: 12018: 12020: 22023: 42024: 1
2007high 4 (2023) · low 0 (2008)2025

MAUDE reports naming product code ECI, 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—01
20080—00
20090—00
20100—00
20110—10
20120—01
20130—00
20140—02
20150—01
20160—01
20170—01
20180—01
20190—00
20200—02
20210—00
20220—00
20230—14
20240—01
20250—00
20260—0—

More from Unitek Corp.

23 FDA decisions under this applicant name. See the company

  • K944286Metal-Lined Transcend Ceramic BracketUnitek Corp. · 1994
  • K933501AlastikUnitek Corp. · 1994
  • K940165AlastikUnitek Corp. · 1994
  • K924645Transcend Series 6000 Debonding InstrumentsUnitek Corp. · 1992
  • K924295Debracketing InstrumentUnitek Corp. · 1992

Recent decisions in ECI

The ECI category page

  • K980864Power Coins Glow in the Dark LigaturesOrtho Kinetics Corp. · 1998
  • K980053Glenroe ChainGlenroe Technologies · 1998
  • K973495Glenroe Glow in Dark Elastomeric LigaturesGlenroe · 1997
  • K943419Orthodontic Elastomeric Lagature ModuleJon-Ko Products, Inc. · 1995
  • K943417Orthodontic Elastomeric Tube/ThreadJon-Ko Products, Inc. · 1995

https://510kreport.com/device/K923999 · printed Nov 4, 2026

Cite this page

510(k) Report. “K923999: Alastik NS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K923999

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