Instructions for Use
Device Description: The enCore Night Guard is a custom-made night guard.
Indication for Use: The enCore Night Guard is indicated for the protection of teeth and restorations against the forces of bruxism and alleviate temporomandibular joint, jaw, and muscle and tension headache pains.
Caution: Rx only. Federal law restricts this device to sale by or on the order of a physician.
Caution: If you experience pain or discomfort in your jaw joints, begin having increased headaches or any of your teeth become tender to chew on, discontinue use of your guard and contact enCore customer service.
Warning: If you have an allergic reaction, please discontinue use immediately, and contact enCore customer service.
Contraindications:
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Patients with poor oral hygiene
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Patients with active periodontal disease
Precautions:
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enCore Night Guards are non-sterile.
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Accidental swallowing of Night Guards may be harmful.
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Clean the enCore Night Guard as instructed.
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Keep your night guard away from children and pets.
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Do not eat or drink (except water) with your night guard in.
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Keep your night guard out of excessive heat.
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Brush and floss your teeth prior to use to prevent trapping food and bacteria on your teeth.
Complications: enCore Night Guards can cause side effects; however, these side effects occur in only a small number of people. Your doctor can monitor you for them. These side effects often go away if the enCore Night Guard is removed. These side effects include:
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Discomfort
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Tissue Damage
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Crown Removal
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Nerve Damage
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Periodontal Disease
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Injury from Night Guard
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Ingestion of Night Guard
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Temporomandibular Joint Dysfunction
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Occlusal Adjustment
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General Health Problems
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Allergic Reaction
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Complications due to the use of tobacco products
If any of the complications mentioned above do occur, a referral may be necessary to your family dentist or another dental or medical specialist for further treatment.
Recommended Procedure:
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Insert your night guard before bedtime
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Wear the night guard throughout the night
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Remove the night guard in the morning.
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Clean the night guard by rinsing with water.
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Place the night guard its case in a safe location.
Period of Use/Storage:
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It is recommended to replace the night guard every 3-6 months to prevent the buildup of dental plaque that may affect your dental health.
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Store night guard in provided case when not in use.
enCore Laboratory
1520 Brookhollow Dr, Suite 38
Santa Ana, CA 92705 LB-003 Rev. 1
Doc ID: a04b0ec2a01f56d110d114ca5c2e0dd3733e152a