510(k) · Cleared
ClearedT-8000 Therozone Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therozone USA, Inc. · EIA Unit, Operative Dental
Cleared on Feb 24, 2015 as substantially equivalent to K991946 (Sterilex Corp., 1999) and 1 other predicate after a 263-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 24, 2015
- Review
- 263 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964796 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK964796 Odyssey I Dental Water UnitGermiphene Corp. · 1997
- This deviceK141504 T-8000 Therozone UnitTherozone USA, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964796 | Odyssey I Dental Water Unit | Germiphene Corp. | 1997 | — |
| 0 (this device) | K141504 | T-8000 Therozone Unit | Therozone USA, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K991946 | Ultra-Kleen Powder for Dental Unit Water Lines, Models 513P, 505LSummary page 4…tive Unit (accessory) NAME: DEVICE Class II, per 21 CFR 872.6640 CLASSIFICATION: PRODUCT CODE EIA PREDICATE DEVICES: UltraKleen(K991946) Odyssey Dental Water Unit (K964796) Substantially Equivalent To: The T-8000 TherOzone Unit is substanti… | 1999 |
| * | K964796 | Odyssey I Dental Water UnitSummary page 4…lass II, per 21 CFR 872.6640 CLASSIFICATION: PRODUCT CODE EIA PREDICATE DEVICES: UltraKleen(K991946) Odyssey Dental Water Unit (K964796) Substantially Equivalent To: The T-8000 TherOzone Unit is substantially equivalent in intended use, principal of operation an… | 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141504 · printed Nov 5, 2026
Cite this page
510(k) Report. “K141504: T-8000 Therozone Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K141504
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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