510(k) · Cleared
ClearedVatea Endontic Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Redent Nova, Ltd. · NYL Handpiece, Air-Powered, Root Canal Irrigation
Cleared on May 28, 2010 as substantially equivalent to K991035 (Sybron Dental Specialties, Inc., 1999) after an 86-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- May 28, 2010
- Review
- 86 days
- Class
- Class I
- Product code
- NYL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991035 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991035 Quantec-E Irrigation SystemSybron Dental Specialties, Inc. · 1999
- This deviceK100606 Vatea Endontic Irrigation SystemRedent Nova, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991035 | Quantec-E Irrigation System | Sybron Dental Specialties, Inc. | 1999 | — |
| 0 (this device) | K100606 | Vatea Endontic Irrigation System | Redent Nova, Ltd. | 2010 | — |
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 NYL? 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 NYL device
- #1 K211721 PS Systemscore 5.7 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K991035 | Quantec-E Irrigation SystemSummary page 1…cessories Product code: NYL Classification panel: 872.4200 Class:I Panel: Dental Predicate Devices Quantec-E Irrigation System (K991035), Sybron Dental Specialties Inc., CA, US. Intended Use /Indications for Use The VATEA system is intended to be a… | 1999 |
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 NYL devicesNYL Handpiece, Air-Powered, Root Canal Irrigation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NYL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NYL
Too few NYL 510(k)s in any year since 2007 to give a median.
Recalls per year · NYL
No recall names NYL since 2007.
Adverse event reports per year · NYL
No MAUDE report names NYL 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 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 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 VATEA system is intended to be attached to dental handpieces to deliver irrigation during endodontic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100606 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100606: Vatea Endontic Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100606
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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