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FDA 510(k), K123731, BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
FDA 510(k), K123731, BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
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$149.00 USD
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$149.00 USD
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510(K) Number: K123731
Device Name: BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
Manufacturer: PAUL KRUMM
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: 12/05/2012
Date Received: 01/04/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
Device Name: BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
Manufacturer: PAUL KRUMM
Device Classification Name: Saliva, Artificial
Regulation Number: LFD
Classification Product Code: 12/05/2012
Date Received: 01/04/2013
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Dental
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