premier 97288 Enamelon Preventive Treatment Gel Instruction Manual
- June 4, 2024
- Premier
Table of Contents
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):
- Extrude a strip of Enamelon Treatment Gel into the tray or directly apply to the teeth.
- Apply the treatment gel to teeth and let sit for a minimum of 1 minute.
- Ask the patient to expectorate thoroughly and if possible avoid rinsing.
- 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.
610-239-6000 • premierdentalco.com
To obtain an SDS or IFU, visit
www.premierdentalco.com
or call Premier at 610-239-6000.