510(k) · Cleared
ClearedVista Dyes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inter-Med/Vista Dental Products · LFC Device, Caries Detection
Cleared on Mar 11, 2020 as substantially equivalent to K955445 (Danville Engineering, Inc., 1996) after an 89-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Mar 11, 2020
- Review
- 89 days
- Class
- Class II
- Product code
- LFC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955445 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK955445 Caries FinderDanville Engineering, Inc. · 1996
- This deviceK193447 Vista DyesInter-Med/Vista Dental Products · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955445 | Caries Finder | Danville Engineering, Inc. | 1996 | — |
| 0 (this device) | K193447 | Vista Dyes | Inter-Med/Vista Dental Products | 2020 | — |
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 LFC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFC device
- #1 K222560 BlueCheck™ Caries Detection & Monitoringscore 5.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K955445 | Caries FinderSummary page 4…etary Name: Vista Dyes Common Name: Device, Caries Detection Product Code: LFC Device Class: Class II 3. Primary Predicate Caries Finder (K955445) by Danville Engineering, Inc. o Common Name: Device, Caries Detection o Product Code: LFC o Device Class… | 1996 |
| † | K964430 | Pulpdent Snoop | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LFC devicesLFC Device, Caries Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · LFC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFC
Too few LFC 510(k)s in any year since 2007 to give a median.
Recalls per year · LFC
No recall names LFC since 2007.
Adverse event reports per year · LFC
1in 2009
MAUDE reports naming product code LFC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 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 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
A visual aid for the identification of carious dentin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193447: Vista Dyes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193447
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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