510(k) Report

510(k) · Cleared

Cleared

Microlux/Blu

K072309510(k) TraditionalCleared Nov 19, 200794-day reviewClass I21 CFR 872.4630

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

Addent, Inc. · EAZ Light, Operating, Dental

Cleared on Nov 19, 2007 after a 94-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Nov 19, 2007
Review
94 days
Class
Class I
Product code
EAZ
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 K072309Source: 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 EAZ? 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 EAZ devices

EAZ Light, Operating, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EAZ

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EAZ

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

Recalls per year · EAZ

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · EAZ

4in 2025

2007: 42008: 42009: 72010: 122011: 162012: 212013: 182014: 132015: 132016: 92017: 112018: 102019: 42020: 32021: 82023: 22024: 72025: 4
2007high 21 (2012) · low 0 (2022)2025

MAUDE reports naming product code EAZ, 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
20071—14
20080—04
20090—07
20100—012
20110—116
20120—021
20130—018
20140—013
20150—013
20160—09
20170—011
20180—010
20190—04
20200—03
20210—08
20220—00
20230—02
20240—07
20250—04
20260—0—

More from Addent, Inc.

7 FDA decisions under this applicant name. See the company

  • K182017Compex HDAddent, Inc. · 2019
  • K121282Microlux/DL Microlux/Blu Bio/ScreenAddent, Inc. · 2012
  • K082668Bio-ScreenAddent, Inc. · 2009
  • K062961Microlux TransilluminatorAddent, Inc. · 2007
  • K061395Calset Composite HeaterAddent, Inc. · 2006

Recent decisions in EAZ

The EAZ category page

  • K041614Microlux DLAddent, Inc. · 2005
  • K033033Vizilite-Blue Oral Exam KitTrylon Corp. · 2004
  • K003995Speculite/OralliteTrylon Corp. · 2001
  • K926081Dental LightMdt Corp., Inc. · 1994
  • K935390Sirolux FantasticPelton & Crane Co. · 1993

https://510kreport.com/device/K072309 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072309: Microlux/Blu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072309

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