510(k) · Cleared
ClearedMicrolux DL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Addent, Inc. · EAZ Light, Operating, Dental
Cleared on Apr 4, 2005 as substantially equivalent to K012070 (Trylon Corp., 2001) and 1 other predicate after a 293-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- Apr 4, 2005
- Review
- 293 days
- Class
- Class I
- Product code
- EAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K003995 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK003995 Speculite/OralliteTrylon Corp. · 2001
- This deviceK041614 Microlux DLAddent, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| 0 (this device) | K041614 | Microlux DL | Addent, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K012070 | Orallite Comprehensive Exam TraySummary page 1…the same purpose as the Speculite/OraLite manufactured by Trylon Corp. Itis also sold under the name Visilite TM by Zila, Inc. The 510K number of the predicate device is K01 2070 and K003995. The OraLite uses a chemical luminescent light source that produces a diffused blue-white light. The Microlux DL use… | 2001 |
| * | K003995 | Speculite/OralliteSummary page 1…ose as the Speculite/OraLite manufactured by Trylon Corp. Itis also sold under the name Visilite TM by Zila, Inc. The 510K number of the predicate device is K01 2070 and K003995. The OraLite uses a chemical luminescent light source that produces a diffused blue-white light. The Microlux DL uses a blue-whi… | 2001 |
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.
What does this lineage say?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K012070.
How does its category compare?
All EAZ devicesEAZ Light, Operating, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAZ
1in 2007
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAZ
4in 2025
MAUDE reports naming product code EAZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 0 | — | 1 | 16 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 0 | — | 0 | 13 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 10 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 7 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is used as an aid to improve the visualization of oral lesions. It is designed to be used by a dentist or health care provider, in combination with a traditional examination by incandescent light.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041614: Microlux DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041614
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026