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Sylphar Sensitivity Relief Strips are intended to aid in the relief of dentinal sensitivity resulting from cold, heat, acids, or sweets.

Remesense Sensitivity Relief Strips are polyethylene strips with dimensions of approximately 30 x 10 mm. On the strips is a gel which contains a tooth desensitizing agent, dipotassium oxalate. The directions for use provided with the device instruct the patient to apply one or more strips on the of any teeth that are causing sensitivity problems. The dipotassium oxalate in the Remesense Sensitivity Relief Strips device forms oxalate crystals which block the open dentinal tubules, thus preventing the stimuli that may cause the sensitivity. By blocking the tubules, the crystals at the tooth surface stop the signals from hot or cold food reaching the dental nerve, providing a remedy for hypersensitivity. The component parts of the subject device are: - · Outer box with inner plastic sleeve - · Foil pouches (2 or 18 per pack), each containing a single desensitizing strip, mounted on a plastic release backing - The gel on each strip contains glycerin, aqua, potassium oxalate, carbopol, carboxy-methyl-. cellulose (CMC), potassium sorbate, sodium benzoate, sodium hydroxide (NaOH) (50% solution) - Instruction sheet .

Remesense for Sensitive Teeth is intended for use as a tooth desensitizer.

'Sylphar Remesense for Sensitive Teeth' is an identical device to 'Remedent Remesense', cleared for marketing in the US by FDA under K082594. 'Remedent Remesense' was cleared as a 'prescription only' (Rx) device. The purpose of this 510(k) submission is to present additional data so that 'Sylphar Remesense for Sensitive Teeth' may be cleared by FDA for marketing as an 'over-the-counter' (OTC) device in addition to a prescription device under a new name. The labeling, both on the device box and in the instructions sheet provided in the box, has however been revised to include the new product name and provide additional information to better accommodate sale as an OTC device. The component parts of the device are: Outer box, Pre-formed dental tray in a plastic bag, 3 x Two foam strips impregnated with glycerin, aqua, dipotassium oxalate, aroma, EDTA, methylparaben, citric acid and saccharin, Plastic packaging for the foam strips, with foil covering, Instruction sheet. Sylphar Remesense for Sensitive Teeth uses dipotassium oxalate crystals to block the tubules in the teeth of patients suffering from acute tooth hypersensitivity. By blocking the tubules, it stops the signals from hot or cold food reaching the dental nerve, providing a rapid remedy for hypersensitivity.