510(k) · Cleared
ClearedOrallite Comprehensive Exam Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trylon Corp. · MPU Source, Chemiluminescent Light
Cleared on Nov 27, 2001 after a 148-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.
- Decided
- Nov 27, 2001
- Review
- 148 days
- Class
- Class II
- Product code
- MPU
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK012070 Orallite Comprehensive Exam TrayTrylon Corp. · 2001
- 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
- Descendant · 4 generations on · 5 of its ownK101140 Dentlight Oral Exam Light KitDentlight, Inc. · 2010
- Descendant · 5 generations on · 3 of its ownK210550 VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- 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
- K101140Dentlight Oral Exam Light KitDentlight, Inc. · 2010 · 4 generations on5descendants
- K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc. · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012070 | Orallite Comprehensive Exam Tray | Trylon Corp. | 2001 | — |
| +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 | — |
| +4 | K101140 | Dentlight Oral Exam Light Kit | Dentlight, Inc. | 2010 | — |
| +5 | K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MPU? 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (11)
See all 112 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, K033033 (Trylon Corp., 2004) has gone furthest, with 9 descendants of its own.
How does its category compare?
All MPU devicesMPU Source, Chemiluminescent Light: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPU
FDA has decided no MPU device since 2007.
Median 510(k) review, days · MPU
Too few MPU 510(k)s in any year since 2007 to give a median.
Recalls per year · MPU
No recall names MPU since 2007.
Adverse event reports per year · MPU
No MAUDE report names MPU since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OralLite Test Kit, when used in combination with conventional visual oral mucosal examination by health care providers, improves identification, evaluation, and monitoring of oral mucosal abnormalities in a patient population at increased risk for oral cancer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012070: Orallite Comprehensive Exam Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012070
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026