510(k) · Cleared
ClearedTheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dr. Harold Katz, LLC (Dba Therabreath · LFD Saliva, Artificial
Cleared on Mar 16, 2018 as substantially equivalent to K152201 (Medactive Oral Pharmaceuticals, LLC, 2015) and 1 other predicate after a 294-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Mar 16, 2018
- Review
- 294 days
- Class
- Class U
- Product code
- LFD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K874106 (1988). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK874106 Glandosane (Salivart) Synthetic SalivaFresenius USA, Inc. · 1988
- 6 generations backK991938 Caphosol Artificial SalivaInpharma A.S. · 1999
- 5 generations backK024148 Salinum, OrclairSinclair Pharmaceuticals, Ltd. · 2003
- 4 generations backK051812 Tgo SprayLaboratoires Carilene S.A.S. · 2005
- 3 generations backK061331 Oral Balance Liquid/ GelLaclede, Inc. · 2006
- 2 generations backK101477 Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth MouthwashGlaxosmithkline Consumer Healthcare (Gskch) · 2010
- 1 generation backK111250 Dry Mouth MouthwashDr. Fresh, Inc. · 2012
- This deviceK171542 TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth LozengesDr. Harold Katz, LLC (Dba Therabreath · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K874106 | Glandosane (Salivart) Synthetic Saliva | Fresenius USA, Inc. | 1988 | — |
| −6 | K991938 | Caphosol Artificial Saliva | Inpharma A.S. | 1999 | — |
| −5 | K024148 | Salinum, Orclair | Sinclair Pharmaceuticals, Ltd. | 2003 | — |
| −4 | K051812 | Tgo Spray | Laboratoires Carilene S.A.S. | 2005 | — |
| −3 | K061331 | Oral Balance Liquid/ Gel | Laclede, Inc. | 2006 | — |
| −2 | K101477 | Biotene Dry Mouth Mouthwash, Biotene PBF Dry Mouth Mouthwash | Glaxosmithkline Consumer Healthcare (Gskch) | 2010 | — |
| −1 | K111250 | Dry Mouth Mouthwash | Dr. Fresh, Inc. | 2012 | — |
| 0 (this device) | K171542 | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges | Dr. Harold Katz, LLC (Dba Therabreath | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 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 LFD? 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 LFD device
- #1 K253778 Allday Moisturizing Rinsescore 11.2 · 2 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 |
|---|---|---|---|
| * | K152201 | MedActive Oral Gel and SpraySummary page 4…lly marketed predicate device: MedActive Oral Relief Spray and MedActive Oral Relief Gel, marketed by Medactive Oral Pharmaceuticals, LLC, Premarket Notification Number: K152201, FDA Product Code LFD (Saliva, Artificial; Unclassified); and to the reference devices: Dr. Fresh Orazyme Dry Mou… | 2015 |
| * | K111250 | Dry Mouth MouthwashSummary page 5…ial; Unclassified); and to the reference devices: Dr. Fresh Orazyme Dry Mouth Mouthwash marketed by Dr. Fresh, LLC, 510(k) Premarket Notification Number: K111250, FDA Product Code LFD (Saliva, Artificial; Unclassified); and, SST 100 Lozenges marketed by Hexim Pharmaceuticals, 510(k) Premark… | 2012 |
| † | K023046 | SST Saliva Supporting Tablets | 2002 |
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?
- The line of descent spans 30 years and passes through 8 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
How does its category compare?
All LFD devicesLFD Saliva, Artificial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · LFD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFD
287in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFD
11in 2025
MAUDE reports naming product code LFD, 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 | 2 | — | 1 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 3 | 83 | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 209 | 0 | 5 |
| 2012 | 2 | — | 0 | 7 |
| 2013 | 2 | — | 1 | 37 |
| 2014 | 0 | — | 0 | 19 |
| 2015 | 5 | 156 | 0 | 28 |
| 2016 | 0 | — | 0 | 68 |
| 2017 | 3 | 231 | 0 | 51 |
| 2018 | 5 | 210 | 0 | 37 |
| 2019 | 3 | 287 | 0 | 40 |
| 2020 | 1 | — | 0 | 34 |
| 2021 | 2 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 1 | — | 0 | 10 |
| 2024 | 2 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 11 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
TheraBreath Dry Mouth Oral Rinse is intended for relief of dry mouth symptoms and is indicated for use to refresh, moisturize, lubricate and soothe the oral cavity, and alleviate discomfort due to dry mouth.
TheraBreath Dry Mouth Lozenges are intended for relief of dry mouth symptoms, and are indicated for use to refresh, moisturize, lubricated, and soothe the oral cavity, and alleviate discomfort due to dry mouth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171542 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171542: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171542
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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