POWER RESINS Clear Smile Resin Instruction Manual

POWER RESINS CLEAR SMILE RESIN
Instruction for Use
Publish Date: 28.12.2023

Intended Use

Power Resins Clear Smile Resin is a 3D printer resin specially developed for non-therapeutic applications in the mouth.
PowerResins Guard resin is biocompatible (Class I) and CE certified.

Indications

PowerResins Clear Smile Resin is a light-cured 3D printed material. It can remain in the patient’s mouth for up to 30 days.

Contraindications

PowerResins Clear Smile Resin should not be used for any purpose other than intraoral applications. Any deviation from these instructions for use may adversely affect the chemical and physical quality of the 3D product. In case of allergic reaction, please consult a medical practitioner.

Mechanism of Effect

Radicals in the light-activated resin bind the monomers and oligomers in the resin, reducing mobility and converting the images sent through the 3D device into solid models

Patient Population

It is suitable for use in all patients regardless of age and gender.

User Audience

The product is used by dentists and dental technicians.

Side Effects

The product has no known side effects.

Warnings and Precautions

Liquid form;
Skin contact
Sensitization or irritation due to skin contact is possible. Repeated and/or prolonged skin contact may cause inflammation.
Eye contact
High air concentrations may cause eye irritation. If it gets into eyes, rinse with plenty of water. Remove contact lenses. If skin irritation or rash occurs: Get medical advice/attention.
Ingestion
Low oral toxicity; however, ingestion may cause irritation of the gastrointestinal tract.
Caution: For full compatibility and biocompatibility, Power Resins Clear Smile Resin should be used with a dedicated resin tank, printing tray and finishing kits.

PowerResins Clear Smile Reçinesi,
Hazardous Component: Phenylbis(2,4,6-trimethyl benzoyl)-phosphine oxide

Warning!
H315 – Causes skin irritation.
317 – May cause an allergic skin reaction.
H319 – Causes serious eye damage.
H411 – Toxic to aquatic life with long lasting effects.
Safety instructions according to SDS
– Wear protective gloves/eye protection.
– Call a doctor/doctor if you feel unwell.
– If skin irritation/redness occurs: seek medical advice/attention.
– If eye irritation persists: seek medical advice/attention.
– Dispose of contents/container according to local and national regulations.

Safety Instructions

To ensure optimum further processing, please read the information contained in the instructions for use carefully. Incorrect use and failure to observe the information can have a detrimental effect on quality. Nitrile gloves, goggles and a jacket must be worn as a means of protection when working with resin.
The safety instructions and precautions specified in the instructions for use and safety data sheet shall apply to the removal of liquid resin and uncured resin from the model.
A dust mask must also be worn due to possible dust generation during post- press operations

General Information Regarding Transportation

Delivery
PowerResins Clear Smile resin; supplied in light-proof, sealed bottles.
Please check the following points when receiving the goods:
– Integrity of the bottle / package
– Quantity
– Color
– Shipment documents and description
Storage conditions
The resin bottle should be kept between 5-25°C. The minimum shelf life date printed on the product must be observed. Store this product in tightly closed containers, in a properly ventilated storage area, in dry conditions, away from sparks and open flames.
Avoid exposing the material to direct sunlight. Shelf life is 2 years from production. Perfect processing cannot be guaranteed when using materials with an expired minimum shelf life.
Please refer to the Material Safety Data Sheet for additional information.

Production Steps

Processing
PowerResins Clear Smile Resin is designed to work with all LCD and DLP 3D printers. See
Printer Settings on powerresins.com for optimization databases.
Cleaning:
It is recommended to use nitrile gloves and protective glasses during the cleaning process.

1. Remove the printing platform from the machine.
2. After separating the printed models from the platform with a suitable tool, cut the supports of the model and remove them.
3. Dry the resin on the model by removing it with the help of an air compressor.

Final Curing

Caution: Final curing outside recommended settings may lead to inadequate mechanical and biocompatibility properties. For best possible results, only apply post-cure in accordance with Power Resins’ official recommendations.
Recommended post-cure treatment

A. If you have an Oto-Flash G-171 curing device;

1. Curing: The Oto-Flash G-171 is exposed to 1000 exposures under nitrogen atmosphere.
2. The product is ready to use.

B. If you have a Medifive TwinCure (or similar) curing device;

1. Environmental Conditioning: The model is thrown into a transparent container containing 20 degree Glycerin. The transparent container containing the model containing 20 degree Glycerin is carefully placed into the TwinCure device and the lid of the device is closed.
2. Curing: TwinCure is set to 10 minutes at level 3 and curing is started.
3. After curing is complete, the model is removed from the glycerin and washed with clean water until the glycerin residue is gone and dried with an air compressor.
4. The product is ready to use.

Supporting Documents

Power Resins Clear Smile Reçinesi SDS

Biocompatibility

Cured PowerResins Clear Smile Resin is non-cytotoxic, non-sensitizing, non- irritating and compliant with ISO 10993.

Radioactivity

There is no radioactive effect in our products.

Label Symbols

| Manufacturer
---|---
| Manufacturing date
| Country of manufacture
| Reference code
| Batch code
| Expiration date
| Color of the product
| Keep away from sunlight
| CE symbol
| Medical device- Type 4 sembolün altına yazılmalı
| Keep dry
| Caution
| instructions for use are available in an electronic format, read it.
| Do not reuse
| Non-sterile
| Store between 5-25°C

Power Resins is a brand of
3BFAB Teknoioji A.$.Company
tnlamurkuyu Mah. Canakkale Cad.
Eren Plaza No: 5 Istanbul, Turkey
P. +90 216 612 00 94-95
info@powerresins.com
SRN: TR-MF-000040768

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