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MSDS

Simplicity Instructions

GENERAL INFORMATION

Simplicity® is a no rinse bonding system that combines the etchant and primer application into one simple step. It allows for more predictable clinical results, it is less technique sensitive, without sacrificing shear bond strength. Because there is no need to rinse the etchant before primer application, Simplicity® also saves time during the procedure. It is intended for use with all categories of resin composite materials. Simplicity® is compatible will all methacrylate-based materials.

The Principal uses of Simplicity® are:

Direct Restorations: to bond enamel / dentin prior to restoring with light-cure or self-cure composite materials
Indirect Restorations: bonding light-cured, self-cured or dual-cured composite cement or glass ionomer or resin-modified glass ionomer cement
Desensitization: to treat hypersensitive and/or exposed root surfaces
Bonding posts and cores
Bonding veneers


INSTRUCTIONS FOR USE

Although it is not critical to the success of Simplicity®, it is recommended that the preparation be cleaned with isopropyl alcohol on a cotton pellet and rinsed with water prior to beginning the bonding protocol.

Rinse the preparation thoroughly and remove all visible water by drying the surface for approximately 5 seconds with dried compressed air. Do not desiccate the tooth surface.

The Simplicity® kit contains red microbrush tips, blue ultrabrush (bristle-type) tips, and a dual-ended applicator handle. Insert one of each type tip into the two ends of the applicator handle using a twisting motion.

A drop of Simplicity® 1 is dispensed into one well of the small white plastic holding tray.

With the red microtip applicator, apply Simplicity® 1 (a clear solution) to the preparation and gently agitate it on the preparation for 10 seconds. DO NOT DRY Simplicity 1.

Dispense a drop of Simplicity® 2 into the other well of the white holding tray (dispense Simplicity® 2 just prior to using). For very large preps, two drops may be required. Fully immerse the blue ultrabrush tip into the Simplicity® 2 (a yellow solution). Apply 3 brushfuls of Simplicity® 2 to the cavity prep.

With the air pressure set at 40 lbs. dry the preparation for 5 seconds from two inches distance with the air stream perpendicular to the cavity floor.

Apply two additional full brushes of Simplicity® 2 and thoroughly dry again similarly for 5 seconds.

Light-cure the adhesive for 10 seconds. If unsure about the light output, light cure for 20 seconds.

In class I and class II restorations, it is highly recommended that a thin layer (0.5 mm) of a low viscosity flowable resin composite be placed on the pulpal floor of the cavity and light-cured prior to insertion of the restorative material.

Prior to using a self-cure or dual-cure composite or cement, apply one more coat of Simplicity 2 and dry but do not light-cure, or place a thin layer of a low-viscosity flowable resin composite and light cure according to manufacturers instructions.

NOTE: Deciduous teeth are treated in the same manner as permanent teeth.
NOTE: Simplicity 1 should be agitated for 10 seconds on uncut enamel.
NOTE: Simplicity® is always light-cured before placing veneers and bonded crowns.

STORAGE

Protect from sunlight and maintain temperatures between (0°C/32°F and 30°C/85°F). Refrigeration when not in use and refrigeration of unopened bottles is recommended. This product is subject to evaporation, keep bottles tightly capped. See individual component labels for specific expiration dates.

CAUTIONS

Avoid splashing into the eyes. If it comes into contact with the eyes, flush with copious amounts of water and seek medical attention. Un-polymerized resins may cause skin sensitization to susceptible persons. In case of contact with the skin, wash thoroughly with soap and water.

WARRANTY

Apex Dental Materials, Inc. recognizes its responsibility to replace products if proven to be defective. Apex Dental Materials, Inc. does not accept liability for any damage or loss, either direct or consequential, stemming from the use of or inability to use the products described. Before using, it is the responsibility of the user to determine the suitability of the product for its intended use. The user assumes all risk and liability in connection therewith.

CAUTION: U.S Federal law restricts this device to sale by or on the order of a dental professional