IFU PeriAcryl®90 High Viscosity

Intended Use

PeriAcryl®90 High Viscosity is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.

Caution: Federal Law (USA) restricts this device to sale by or on the order of a dentist. (Rx Only)

Contraindications

PeriAcryl®90 High Viscosity must not come into contact with the conjunctival sac since conglutination may occur. 

Description

The primary ingredient is the n-butyl ester of the cyanoacrylate series. This compound which exists in monomeric form in the plastic containers polymerizes extremely rapidly in the presence of anions, especially of hydroxyl ions [in the presence of water]. It has the ability to adhere to moist living tissues. It demonstrates a favorable tissue response and reveals no toxic or foreign body reactions.

Method

Peel open protective pouch containing the 5 mL bottle and discard pouch. Be sure to examine the adhesive prior to beginning the procedure. Only adhesive of a consistency similar to olive oil should be used. If the material appears to be overly sluggish or solid, do not use. Report this occurrence to your supplier.

MULTIUSE KIT: To open, while holding the base of the cap, rotate the top piece counterclockwise. There is a pin in the cap to keep the opening patent. The adhesive can be drawn up directly from the bottle using a disposable pipette. To use this method, compress the bulb end of one of the accompanying pipettes and while compressing, insert the tip of the pipette into the opening of the bottle. Tilt the bottle so the cyanoacrylate comes in contact with the pipette. Slowly release the bulb so that the cyanoacrylate is drawn into the pipette. The material is now ready to apply to the surface being treated. The adhesive may also be dispensed into the tray provided, and then drawn up using a disposable pipette.

 Closing and Storage of Bottles

Ensure that the tip and cap are clean and dry by removing excessive adhesive with a dry paper towel after each use. Replace and securely fasten the cap. Store upright in a refrigerator or freezer. PeriAcryl®90 High Viscosity will not freeze. Cooler temperatures help PeriAcryl®90 retain the best performance characteristics over the two-year shelf life.

Important Recommendations

Whenever the adhesive is used, care must be taken that none splashes onto the cornea of the eye or into the conjunctival sac, where it would cause adhesions.

Use the following technique to speed up the polymerization process and for improved flow control. Apply a small amount of PeriAcryl®90 to the target site and spread into a thin film with the pipette. Use a moist 2 x 2 cotton gauze or moist cotton swabs to introduce water on top of the adhesive to speed polymerization. Do not allow the applicator to dwell on the target site as it may adhere to the site.

Supplied

PeriAcryl®90 High Viscosity MULTIUSE KIT: One x 5 mL cyanoacrylate, 50 pipettes, autoclavable tray.

Visit us at www.glustitch.com to download the SDS sheet.                                                

                                                                                                                        6033-3 Rev D

                                                                                                                        25 Feb 2015
_linkedin_partner_id = "1412020"; window._linkedin_data_partner_ids = window._linkedin_data_partner_ids || []; window._linkedin_data_partner_ids.push(_linkedin_partner_id);