# K171542: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges

- Pathway: 510(k) (Traditional)
- Applicant: Dr. Harold Katz, LLC (Dba Therabreath
- Decided: Mar 16, 2018 after 294 days
- Product code: LFD (Saliva, Artificial)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K874106 (1988). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152201: MedActive Oral Gel and Spray, Medactive Oral Pharmaceuticals, LLC (2015) Summary page 4.
- K111250: Dry Mouth Mouthwash, Dr. Fresh, Inc. (2012) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K171542
Methodology: https://510kreport.com/methodology