premier Glitter Professional Prophylaxis Paste Instruction Manual

June 4, 2024
Premier

premier Glitter Professional Prophylaxis Paste

premier-Glitter-Professional-Prophylaxis-Paste-product

Manufacturer:
Premier® Dental Products Company 1710 Romano Drive, Plymouth Meeting, PA 19462 U.S.A. 888-670-6100 610-239-6000 premierdentalco.com

Intended Use

It is to be used as a preventative treatment. It is intended to polish and clean teeth with varying grit particulate of silica as an abrasive agent. In packages indicating that Glitter contains fluoride, it is present at a concentration of 1.23% fluoride ion.

Indications for Use

Indicated for normative preventative dental treatments for stain removal and polishing

Available in the following grits:

  • Fine For gentle polishing, ideal for younger patients.
  • Medium For normal adult cleaning procedures where high level of polish and plague removal is desired.
  • Coarse For adult patients with substantial stain build-up.
  • Extra Coarse For those select patients who have stain build-up difficult to remove.

Product Description:
Product line containing professional prophylaxis paste for tooth cleaning and polishing containing fluoride provided in a variety of flavors. Non-fluoride formulations are optional.

Contraindications:
Do not use under the following conditions Product contains fluoride, if patient displays or has a history of fluoride sensitivity.

PRECAUTIONS

  • Keep product stored within its original packaging and within the storage conditions as indicated on the labeling.
  • Single patient use only. Do not reuse.
  • Rx only, Prescription device

WARNINGS

  • Harmful if swallowed: Fluoride ingestion can cause nausea.
  • Causes serious eye irritation.
  • Causes skin irritation.

Adverse Reactions:
Nausea and vomiting may occur from the ingestion of pastes. 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

Refer to premierdentalco.com for a full list of flavors and offerings.

Materials:
In packages indicating that Glitter contains fluoride, it is present at a concentration of 1.23% fluoride ion. Contains different grade pumice as abrasive material. Abrasiveness of pumice varies with grit.

Directions for Use:

  1. Unit dose cups – Each cup contains enough Glitter Paste for one (1) prophylaxis procedure.
  2. Using any commercially available Prophy angle – rubber cup combination.
  3. Fill the cup by pressing the face of the cup into the paste while running the angle at low speed. All contents in the cup will provide the same benefits to you patient’s teeth.
  4. Throughout the procedure, sufficient paste should be maintained on the cup to avoid overheating of the tooth surface.
  5. Saliva evacuation is recommended to avoid excess dilution and swallowing of the paste.
  6. Should you find the paste too dry for your preference, simply add a drop or two drop of water to soften.

Storage:
Store in temperature conditions of 15° (59°) to 30° (86°) and away from direct sunlight.

Shelf Life:
Shelf life of the product is two (2) years from the date of manufacturing and labeled on the product.

For Further Information:
To obtain SDS or IFU, visit premierdentalco.com or call Premier at 610-239-6000.

premier-Glitter-Professional-Prophylaxis-Paste-fig-1

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