FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
K Number: K123731
·
Decision Jan 4, 2013
Classifications
1
FEI Numbers
39
Registration Numbers
40
Same Product Code
49
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
- K Number
- K123731
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Glaxosmithkline Consumer Healthcare (Gskch)
- Date Received
- December 5, 2012
- Decision Date
- January 4, 2013
- 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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