FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
K Number: K171542
·
Decision Mar 16, 2018
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
1
Review Days
294
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Basic Information
- Device Name
- TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
- K Number
- K171542
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dr. Harold Katz, LLC (Dba Therabreath
- Date Received
- May 26, 2017
- Decision Date
- March 16, 2018
- Product Code
- LFD
- Advisory Committee
- Unknown
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LFD | Saliva, Artificial | FDA unclassified | Unknown |
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