510(k) Report

510(k) · Cleared

Cleared

Transcend Series 6000 Debonding Instruments

K924645510(k) TraditionalCleared Nov 25, 199272-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

Unitek Corp. · JEX Plier, Orthodontic

Cleared on Nov 25, 1992 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 25, 1992
Review
72 days
Class
Class I
Product code
JEX
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K924645Source: 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 JEX? 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 has not posted a summary or statement for it, 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 JEX devices

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

FDA decisions per year · JEX

FDA has decided no JEX device since 2007.

Median 510(k) review, days · JEX

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

Recalls per year · JEX

No recall names JEX since 2007.

Adverse event reports per year · JEX

1in 2022

2007: 82008: 12009: 12010: 22011: 12012: 12015: 12016: 12018: 12019: 22020: 12021: 32022: 1
2007high 8 (2007) · low 0 (2013)2025

MAUDE reports naming product code JEX, 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—08
20080—01
20090—01
20100—02
20110—01
20120—01
20130—00
20140—00
20150—01
20160—01
20170—00
20180—01
20190—02
20200—01
20210—03
20220—01
20230—00
20240—00
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
  • K923999Alastik NSUnitek Corp. · 1993
  • K924295Debracketing InstrumentUnitek Corp. · 1992

Recent decisions in JEX

The JEX category page

  • K955242Titanium Bird Beak PlierSybron Dental Specialties, Inc. · 1995
  • K935141Dentaurum PliersDentauraum, Inc. · 1994
  • K924295Debracketing InstrumentUnitek Corp. · 1992
  • K854088Unitek Lift-Off Debracketing InstrumentUnitex Corp. · 1985
  • K843742Unitek Convertible Cap Remover ToolUnitek Corp. · 1984

https://510kreport.com/device/K924645 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924645: Transcend Series 6000 Debonding Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924645

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