510(k) · Cleared
ClearedSpeculite/Orallite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trylon Corp. · EAZ Light, Operating, Dental
Cleared on Mar 16, 2001 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 15 later devices descend from it.
- Decided
- Mar 16, 2001
- Review
- 80 days
- Class
- Class I
- Product code
- EAZ
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 3 citing it directly.
- This deviceK003995 Speculite/OralliteTrylon Corp. · 2001
- Descendant · cites it directly · 12 of its ownK060920 VelscopeLed Medical Diagnostics, Inc. · 2006
- Descendant · 2 generations on · 10 of its ownK070523 Modification to: VelscopeLed Dental, Inc. · 2007
- Descendant · cites it directly · 9 of its ownK033033 Vizilite-Blue Oral Exam KitTrylon Corp. · 2004
- Descendant · 2 generations on · 8 of its ownK082603 Trimira Ocs 3000Remicalm, LLC · 2008
- Descendant · 3 generations on · 7 of its ownK090135 Trimira Identafi 3000Remicalm, LLC · 2009
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K060920VelscopeLed Medical Diagnostics, Inc. · 2006 · cites it directly12descendants
- K070523Modification to: VelscopeLed Dental, Inc. · 2007 · 2 generations on10descendants
- K033033Vizilite-Blue Oral Exam KitTrylon Corp. · 2004 · cites it directly9descendants
- K082603Trimira Ocs 3000Remicalm, LLC · 2008 · 2 generations on8descendants
- K090135Trimira Identafi 3000Remicalm, LLC · 2009 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003995 | Speculite/Orallite | Trylon Corp. | 2001 | — |
| +1 | K060920 | Velscope | Led Medical Diagnostics, Inc. | 2006 | — |
| +2 | K070523 | Modification to: Velscope | Led Dental, Inc. | 2007 | — |
| +1 | K033033 | Vizilite-Blue Oral Exam Kit | Trylon Corp. | 2004 | — |
| +2 | K082603 | Trimira Ocs 3000 | Remicalm, LLC | 2008 | — |
| +3 | K090135 | Trimira Identafi 3000 | Remicalm, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
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
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? (15)
See all 153 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K060920 (Led Medical Diagnostics, Inc., 2006) has gone furthest, with 12 descendants of its own.
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 | — |
https://510kreport.com/device/K003995 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003995: Speculite/Orallite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003995
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026