premier Ziroxide Professional Prophylaxis Paste Instruction Manual
- June 4, 2024
- Premier
Table of Contents
. INSTRUCTIONS FOR USE
Ziroxide™
Professional Prophylaxis Paste
Inspired solutions for daily dentistry
Intended Use:
It is to be used as a preventative treatment. It is intended to be used as deep stain removal and polishing agent which contains large grit particles of zirconium silicate. In packages indicating that Ziroxide contains fluoride, it is present at a concentration of 1.23% fluoride ion.
Indications for Use:
Indicated as a preventative dental treatment to remove tougher stains with
larger grit sizes and polish teeth.
Available in the following grits:
Medium/Fine| For normal adult cleaning procedures where a high level of polish
and plague removal is desired.
---|---
Coarse| For adult patients with substantial stain build-up difficult to
remove.
Product Description:
Product line containing professional prophylaxis paste for polishing and deep
stain removal containing zirconium silicate and fluoride provided in a variety
of flavors. Non-fluoride formulations are optional.
Contraindications:
Do not use under the following conditions –
- The product contains fluoride if the patient displays or has a history of fluoride sensitivity.
PRECAUTIONS:
- Keep the 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:
Available in a natural mint flavor.
Materials:
In packages indicating that Ziroxide contains fluoride, it is present at a
concentration of 1.23% fluoride ion. Non-fluoride formulations will contain
zirconium silicate.
All Ziroxide will contain different grade pumice as the abrasive material. The
abrasiveness of pumice varies with grit.
Directions for Use:
- Unit dose cups – Each cup contains enough Ziroxide Paste for one (1) prophylaxis procedure.
- Bulk Jar – Remove sufficient paste for one procedure and place it in a clean dappen dish or another suitable container.
- Using any commercially available Prophy angle–rubber cup combination.
- 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 your patient’s teeth.
- Throughout the procedure, sufficient paste should be maintained on the cup to avoid overheating of the tooth surface.
- Saliva evacuation is recommended to avoid excessive dilution and swallowing of the paste.
- Should you find the paste too dry for your preference, simply add a drop or two drops of water to soften it.
Storage:
Store in temperature conditions of 15° (59°) to 30° (86°) and away from direct
sunlight.
Shelf Life:
The 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.
| Symbols | Symbol Meaning |
|---|---|
| Temperature Limit | |
| **** | Warning, See IFU |
| SKU | |
| **** | Do not reuse |
| Irritant | |
| Manufacturer | |
| Medical Device | |
| Professional Use Only | |
| UK |
Manufacturer:
Premier® Dental Products Company
1710 Romano Drive,
Plymouth Meeting, PA 19462 U.S.A.
888-670-6100 •
610-239-6000
premierdentalco.com
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germany
premierdentalco.com/promise
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