This is a brief overview of information related to FDA’s approval of an Evaluation of Automatic Class III Designation to market this device.
Device Name: Decapinol Oral Rinse
Manufacturer: Sinclair Pharmaceuticals Limited
Address: Borough Road, Godalming Surrey, GU7 2AB, United Kingdom
Approval Date: April 18, 2005 (Approved Evaluation of Automatic Class III Designation)
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041482.pdf
What is it? Decapinol® is a prescription oral rinse used to treat gingivitis. Gingivitis, the earliest stage of gum disease, is an inflammation of the gums caused by a build up of bacteria that grow in the coating (plaque) that forms on teeth between brushings. Decapinol® Oral Rinse forms a barrier that reduces bacterial attachment to tooth surfaces. The interference with bacterial attachment reduces the formation of plaque associated with gingivitis.
Decapinol® Oral Rinse is used in addition to normal oral hygiene such as brushing and flossing.
How does it work? Decapinol® Oral Rinse reduces the formation of plaque associated with gingivitis by forming a barrier that interferes with bacterial attachment to tooth surfaces.
When is it used? Decapinol® Oral Rinse is used twice daily for one minute after brushing and flossing.
What will it accomplish? Decapinol® Oral Rinse interferes with the attachment of bacteria associated with gingivitis and periodontitis, to tooth surfaces. Decapinol® is used in addition to normal oral hygiene such as brushing and flossing by patients who have gingivitis.
When should it not be used?
- Decapinol® Oral Rinse should not be used by women who are pregnant because there is limited information about the use of Decapinol® Oral Rinse during pregnancy. The sponsor recommended that it not be used during pregnancy.
- Decapinol® Oral Rinse is not recommended for use by children under 12 years of age.