GC COE SOFT PROFESSIONAL PACKAGE

COE-COMFORT is a self-curing, chairside edentulous tissue conditioner used to restore sound form and condition to the underlying tissue. Acting as a cushion to the tissue, a lining of COE-COMFORT allows the denture-bearing tissue to recover and return to a normal, healthy condition.

COE-SOFT is a resilient, self-curing reline material that is used when the patient requires a soft, temporary liner in upper or lower dentures. (Soft Relining material) Acrylic temporary relining material to buffer masticatory pressure for partial and full dentures.COE-SOFT polymerizes in or out of the mouth in approximately 15 minutes. The reline will normally last for approximately 3 months.

INDICATIONS FOR COE-COMFORT:

• Lining of ill-fitting dentures as a tissue conditioner to facilitate recovery of damaged soft tissue
• Functional impression material for full dentures, relining the edentulous area of distal extension partials and construction of obtuarators
• Lining of surgical and periodontal splints
• Diagnostic aid to locate pressure areas on Recommended for optimal performance; store in a dry location at room temperature

CONTRAINDICATIONS

• Patients who have shown sensitivity to the material. In case of allergy, please refer to physician

INDICATIONS FOR COE-SOFT:

A temporary lining for acrylic dentures. For use in chairside procedures.

CONTRAINDICATIONS

Patients who have shown sensitivity to the material including methacrylates and salicylates. In case of allergy, please refer to physician.

Directions to use:

DIRECTIONS FOR USE FOR COE- SOFT

Product Handling:

Use caution when opening. COE-SOFT Liquid is a highly flammable liquid and vapor;keep away from heat, hot surfaces, sparks, flames and other ignition sources. Use with adequate ventilation. Do not ingest or breathe vapor. Personal Protective Equipment (PPE) such as gloves, face masks and safety eyewear should always be worn. Check bottle with liquid before using. Make sure that upon removal of cap, the bottle opening has no obstructions. Some bottles may contain an insert (as a seal). The insert must be in the cap and not obstructing opening. In case of contact, flush eyes with water for at least 15 minutes. Get prompt medical attention. If overcome by vapor, move to fresh air. If breathing is difficult, administer oxygen and seek medical attention. If swallowed, dilute by giving water to drink and seek medical attention. In case of contact with skin wash thoroughly with soap and water.Store securely. Store in a well-ventilated place. Keep cool. Dispose of all waste according to local regulations

I. Preparation of the denture: Relieve and roughen the area of the denture to be relined. Clean and dry the denture thoroughly. Coat labial and buccal surfaces of the denture with COE LUBRICANT. Do not apply coating within 3mm (1/8 inch) of the peripheral border. If the denture has plastic teeth also protect them with COE LUBRICANT. Note: COE-SOFT will not adhere to surfaces coated with COE LUBRICANT.

II. Preparation of COE-SOFT: Recommended powder / liquid ratio is 11g powder to 8ml liquid. Pour the liquid into the large mixing cup. Then add the powder slowly. Stir mixture thoroughly for 30 seconds. A suitable spatula is provided for this purpose. To avoid introducing bubbles into the mixture, do not spatulate for more than 30 seconds. Do not whip.

III. Application:

Spread the mixture of COE-SOFT over the area to be relined. Seat the denture in the manner of taking an impression and instruct the patient to close lightly into occlusion. After 3 minutes instruct the patient to move lips and cheeks so that a muscle trimmed periphery is obtained. Remove the denture and rinse under cold water. Trim away excess material. Re-seat the denture and instruct the patient to close FIRMLY into occlusion and to hold this position for 5 minutes. Remove the denture and rinse again in cold water.

IV. Finishing:

When curing is complete, trim away excess. For smoothing the edges use a hot spatula.

DIRECTIONS FOR USE FOR COE- COMFORT

Tissue Conditioning:

I. Pre-treatment considerations:

The restoration of sound condition to damaged soft tissue takes time, requiring several applications of COE-COMFORT. It is recommended that before starting treatment and at each subsequent visit an impression is taken and a study model poured. Comparison of such casts will demonstrate how well treatment is progressing. If the existing dentures do not provide good tissue coverage and are not in proper centric and vertical relationship, they should be rebased and corrected before beginning treatment. If tissues beneath both upper and lower dentures need treatment consider separate treatments. If not practical, then prepare the upper first and seat it. Then prepare the lower and seat it. Use separate mixes of COE-COMFORT.

II. Preparation of the denture:

Using a handpiece, remove undercuts to relieve the denture to prevent impingement. Wash and dry the denture thoroughly. Coat buccal and labial flanges with COE LUBRICANT to prevent adhesion of COE-COMFORT.

III. Mixing:

Dispense 5mL of COE-COMFORT Liquid into a disposable mixing cup. Fill the red measure level with COE-COMFORT Powder (6g) and add slowly to the liquid. Mix thoroughly for 30 seconds. Set aside the mixture for approximately 1 minute until it flows sluggishly from the spatula. Note:

IV. Lining the denture: Spread the mixture evenly on the surface to be coated, including the peripheral borders. During this time, ask the patient to rinse the mouth thoroughly with cold water. The reduced temperature of the mouth provides a more favorable working time. Insert the denture if taking an impression. Instruct the patient to close VERY GENTLY into occlusion. After the denture has been secured, encourage the patient to talk for a few minutes thus stimulating the tissues. After four or five minutes, remove the denture and rinse thoroughly in cold water. Trim away excess material. Inspect the contact area of the denture for areas of contact impingement where the pink denture resin shows through the white COE-COMFORT. In such cases, relieve the area with a handpiece and wash and dry the denture fully. Make up a small quantity of COE-COMFORT mixture and apply to the freshly relieved area. Instruct the patient to rinse with cold water, reinsert the denture and tell the patient to close VERY GENTLY into occlusion.

V. Further treatment:

Full restoration of tissue to a sound condition takes time and several repeat applications of COE-COMFORT may be necessary. Ask the patient to return 2-4 days after the initial treatment, and each subsequent treatment. At each visit, remove all the COE-COMFORT from the denture using a handpiece and place a new COE-COMFORT lining as described above. Two or three treatments may be sufficient, but continue as often as necessary until you judge that further treatment will bring no further improvement. At this stage, reline the denture using a hard chairside reline material.