The following data is part of a premarket notification filed by Dr. Harold Katz, Llc (dba Therabreath with the FDA for Therabreath Dry Mouth Oral Rinse, Therabreath Dry Mouth Lozenges.
| Device ID | K171542 |
| 510k Number | K171542 |
| Device Name: | TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges |
| Classification | Saliva, Artificial |
| Applicant | Dr. Harold Katz, LLC (dba TheraBreath 5802 Willoughby Avenue Los Angeles, CA 90038 |
| Contact | Harold Katz |
| Correspondent | Barbara S. Fant Clinical Research Consultants, Inc. 3308 Jefferson Avenue, Upper Level Cincinnati, OH 45220 |
| Product Code | LFD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80697029241123 | K171542 | 000 |
| 80697029118838 | K171542 | 000 |
| 00697029507032 | K171542 | 000 |
| 00697029383414 | K171542 | 000 |