premier 97288 Enamelon Preventive Treatment Gel Instruction Manual

June 4, 2024
Premier

97288 Enamelon Preventive Treatment Gel
Instruction Manual

97288 Enamelon Preventive Treatment Gel

Intended Use: Premier® Enamelon® Preventive Treatment Gel is intended for at-home use or by a dental professional as a Preventive treatment to reduce sensitivity, sensitivity, promote remineralization, inhibit demineralization, and soothe and moisturize dry-mouth issues.
Indications for Use: Enamelon Preventive Treatment Gel is indicated to provide a topical coating for high-risk caries patients suffering from erosion or xerostomia or patients with special needs such as hypersensitivity or dry mouth.
Description of Device and Contents: Premier® Enamelon® Preventive Treatment Gel is a clear gel available in a clean mint flavor containing fluoride and ACP to be used after teeth cleaning or polishing.

Contraindications

  • Do not use if gingivitis, bleeding, or redness persists for more than 2 weeks.
  • Do not use if you have known periodontal disease or symptoms of periodontitis.
  • Do not use this product for sensitivity relief for longer than 4 weeks unless recommended by a dentist or doctor.

PRECAUTIONS

Supervise children as necessary until capable of using without supervision

  • For children under 6 years of age, consult a dentist or doctor prior to using
  • Do not eat or drink for 30 minutes following the application

WARNINGS:

  • Keep out of reach of children under 6 years of age.
  • If more than use for brushing is accidentally swallowed, get medical help or contact the poison control center right away.
  • See your dentist immediately if you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth.

Adverse Reactions: Choking or poisoning effects may occur from swallowing excessive amounts of Enamelon Preventive Treatment Gel during use.
If a serious incident has occurred in relation to the device, please report the incident to the Manufacturer and/or competent authority of the Member State where the device was used.
Contents and Setup: Available in 4.0oz (113g) tube REF REF 9007295
Enamel on Preventive Treatment Gel
Materials: Contains 0.40% stannous fluoride

Directions for Use (In-Office):

  1. Extrude a strip of Enamelon Treatment Gel into the tray or directly apply to the teeth.
  2. Apply the treatment gel to teeth and let sit for a minimum of 1 minute.
  3. Ask the patient to expectorate thoroughly and if possible avoid rinsing.
  4. Any gel remaining on the surface can be left to gradually dissipate.

Directions for Use (At Home): Adults and children 6 years of age and older: use once a day, preferably prior to bedtime, to maximize contact time. Supervise Children as  necessary until capable of using without supervision.
Apply the gel to teeth and brush thoroughly for at least 1 minute then spit out. Do not swallow. Do not rinse, eat or drink for as long as possible for maximum benefit – up to  30 minutes after brushing.

Storage:

Close cap after each use.
Store in temperature conditions of 8˚C (46˚F) to 25˚C (77˚F) and away from direct sunlight.
Shelf Life: Shelf life of the product is two years from the date of manufacturing and labeled on the product.
For Further Information:
To obtain SDS or a printable version of the IFU, visit www.premierdentalco.com

Symbols Symbol Meaning
Temperature Limit
Keep away from sunlight
Warning, See IFU
SKU
Manufacturer
Medical Device

Manufacturer:
Premier® Dental Products Company
1710 Romano Drive
Plymouth Meeting, PA 19462 U.S.A.
610-239-6000premierdentalco.com
To obtain an SDS or IFU, visit www.premierdentalco.com
or call Premier at 610-239-6000.

References

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