GC RELINE Chairside Hard Denture Liner Instruction Manual

GC RELINE Chairside Hard Denture Liner Instruction Manual

GC RELINE

CHAIRSIDE HARD DENTURE LINER

For use only by a dental professional in the recommended indications.

RECOMMENDED INDICATIONS

GC RELINE is an acrylic resin used for chairside hard denture linings and extension of denture borders. Its methyl methacrylate-free liquid reduces unpleasant odor and
irritation of the gingival tissue.

CONTRAINDICATIONS

Do not use on patients with known sensitivity to methacrylate. In case of allergy, consult a physician.

DIRECTIONS FOR USE

1. Roughen the area of denture to be relined. Clean and dry the denture thoroughly.

2. Coat the artificial teeth, labial and buccal surfaces of the denture with Vaseline or COE LUBRICANT using a cotton swab. Do not apply coating within 3mm (1/8 inch)
   of the peripheral border. For dentures with plastic teeth, apply a coating of COE LUBRICANT to the teeth to protect them from the GC RELINE material adhering to the tooth surface.

3. Coat the denture to be relined with BONDING AGENT using the enclosed brush. Air dry the solvent for approximately 10 seconds.
   Note: BONDING AGENT is volatile, be sure to close cap tightly after using.for 15 seconds.

4. Using a plastic spatula, apply the resin mix evenly onto the tissue contact surface of the denture.

5. Insert the denture into the mouth at approximately 1 minute from start of the mix. Instruct the patient to close lightly into occlusion. Muscle trim the borders as necessary.

6. For a full denture reline without undercuts: Remove the excess portion of the resin intraorally. Keep the denture in the mouth until curing is completed (approximately 5 minutes and 30 seconds from the start of the mix).

7. For a full denture reline with undercuts or a partial denture: Remove the denture when the material reaches a rubbery state (approximately 2′ to 2’30” from the start of the mix). Trim excess and reseat denture in the mouth before it begins to generate heat. If denture is to remain out of the mouth, place it in warm water (approximately 40° to 50°C = 105° to 120°F) for 3 minutes until completely cured.
   Note: When undercuts or retentive areas are present, the denture should be removed from the mouth while the material is in a rubber-like state and before it begins to generate heat. Otherwise it may be difficult to disengage and remove the denture.

8.  For denture border extensions: Mix material slightly thicker than standard powder/liquid ratio.

9. Remove the denture from the mouth at approximately 5 minutes and 30 seconds from the start of the mix. Finish and polish the denture in a usual manner..

CAUTION

1. Liquid and BONDING AGENT liquid are volatile and flammable, avoid sources of ignition.
2. Wash the brush with GC RELINE liquid or ethanol after applying the BONDING AGENT.
3. Shake the powder bottle lightly before use.
4. In case of contact with skin, wash thoroughly with water.
5. In case of contact with eyes, flush immediately with water and seek medical attention.
6. 6. Personal Protective Equipment (PPE) such as gloves, face masks and safety eyewear should always be worn.

STORAGE

Recommended for optimal performance, store at normal temperature 15-25°C (60-77°F).

PACKAGE

Powder (80g) x 1
Liquid (50mL; 49.7g) x 1
Bonding Agent (12g; 13.2mL) x 1
Mixing Cups x 4
Measure Vial x 1
Dropper x 1
Brush x 1
Spatula x 1

CLEANING AND DISINFECTING RECOMMENDATION

MULTI-USE DELIVERY SYSTEMS: To avoid cross-contamination between patients the bottles and measuring devices require mid-level disinfection. Immediately after use inspect the bottles, measuring devices and label for deterioration. Discard if damaged. DO NOT IMMERSE. Thoroughly clean bottles and measuring devices to prevent drying and accumulation of contaminants. Disinfect with a mid-level registered healthcare-grade infection control product according to regional/national guidelines. Some products referenced in the present IFU may be classified as hazardous according
to GHS. Always familiarize yourself with the Safety Data Sheets available at: or for the Americas:
They can also be obtained from your supplier. http://www.gcamerica.com

Undesired effects – Reporting
If you become aware of any kind of undesired effect, reaction or similar events experienced by use of this product, including those not listed in this instruction for use, please report them directly through the relevant vigilance system, by selecting the proper authority of your country accessible through the following link: https://ec.europa.eu/growth/sectors/medical- devices/contacts_en as well as to our internal vigilance system: vigilance@gc.dental In this way you will contribute to improve the safety of this product.
Last revised: 09/2021

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