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New Device Approval

Decapinol Oral Rinse - K041482

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.fda.gov/cdrh/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?

  1. 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.
  2. Decapinol® Oral Rinse is not recommended for use by children under 12 years of age.

Additional Information:

Information on gingivitis and gum disease:
http://www.perio.org/consumer/gingivitis.htm

Information on gum disease from the American Dental Association:
http://www.ada.org/public/topics/periodontal_diseases.asp

Updated May 17, 2005

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