TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges— 510(k) K171542
Substantially EquivalentDr. Harold Katz, LLC (Dba Therabreath
FDA 510(k) clearance K171542 for TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges, Substantially Equivalent on 2018-03-16. Applicant: Dr. Harold Katz, LLC (Dba Therabreath.
Clearance details
- Applicant
- Dr. Harold Katz, LLC (Dba Therabreath
- Product code
- Code LFD
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Angeles, CA, US
Adverse events under product code LFD
product code LFD- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.