BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY— 510(k) K123731
Substantially EquivalentGlaxosmithkline Consumer Healthcare (Gskch)
FDA 510(k) clearance K123731 for BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY, Substantially Equivalent on 2013-01-04. Applicant: Glaxosmithkline Consumer Healthcare (Gskch).
Clearance details
- Applicant
- Glaxosmithkline Consumer Healthcare (Gskch)
- Product code
- Code LFD
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Parsippany, NJ, 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.