premier 9011102 Pro Clean Stain Cleaner Instruction Manual

Pro Clean™
Inspired solutions for daily dentistry®
INSTRUCTIONS FOR USE

Professional Strength Tartar and Stain Remover for Dentures, Partials, Retainers, and Night Guards

Intended Use:

It is intended to aid in the removal of tartar and stains from Dentures, Partials, Retainers, and Night Guards.
Device Description:
Premier® Pro Clean™ is formulated for at-home or in-office cleaning of tartar and stains from dentures, bridges, and orthodontic appliances.

Contraindications:
Do not use Pro Clean™ under the following conditions:

• Gum sensitivity or open wounds

PRECAUTIONS:

• Thoroughly rinse Dentures, Partials, Retainers, and Night Guards after soaking within Pro Clean
• Single-use unit packets.
• Do not use the package if found damaged.
• Always store products in original protective packaging.
• Avoid over dilution.
• Wash exposed skin and hands thoroughly after handling.
• Contains Sulfamic acid, which may cause eye and skin irritation.

WARNINGS:

• Irritation may occur if not fully rinsed off.
• Remove contact lenses, if exposed.
• EYES – Rinse with large volumes of water for 15 minutes. If irritation persists, seek medical attention.
• SKIN – Rinse with large volumes of water.
• INGESTION – Drink large volumes of water. Contact physician promptly.

Adverse Events:

• May be harmful if swallowed.
• May be harmful if inhaled.
• Moderate eye and skin irritant.

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:

Materials:
The Sulfamic Acid Crystalline formula has a fresh mint scent.

DIRECTIONS FOR USE:

In–Office:

• Add contents of packet into a breaker or resealable plastic bag containing 16oz. of very warm (100-125°F/38-52°C) water.
• Immerse a beaker or sealed plastic bag in an ultrasonic bath for 1-5 minutes, depending on the severity of the stain.
• Rinse thoroughly with tap water after cleaning to remove the residual cleaner from the appliance.

At-Home:

• Add contents of the packet into a container with 16oz. of very warm (100-125°F/38-52°C) water.
• Allow the appliance to soak for at least two (2) hours.
• Rinse thoroughly with tap water after cleaning to remove the residual cleaner from the appliance.

Use one packet per cleaning.

Storage:
Store in a cool, dry place away from direct sunlight.
Shelf Life:
The product does not have a shelf life.
Disposal:
After use, Dispose of as biohazardous medical waste in accordance with the facility or institutional guidelines/procedures.
For Further Information:
To obtain SDS or IFU, visit premierdentalco.com or call Premier at 610-239-6000.

Batch number
Warning, See IFU
Store in a dry cool place
Avoid direct sunlight
Medical Device
UK

Manufacturer:
Premier® Dental Products Company
1710 Romano Drive,
Plymouth Meeting, PA 19462 U.S.A.
888-670-6100 • 610-239-6000 premierdentalco.com
Made in the U.S.A.
MDSS GmbH
Schiffgraben 41
30175 Hannover, Germanypremierdentalco.com/promise
IFU# 90112-2 0421094 Rev0 PDF

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