GC AMERICA Fit Checker Advanced Blue Vpes Silicone for Checking Fit and Occlusal Contact Instructions

: June 6, 2024
: GC AMERICA

Table of Contents

RECOMMENDED INDICATIONS
CONTRAINDICATIONS
PRECAUTION
DIRECTIONS FOR USE
OCCLUSAL CONTACT
PACKAGES
CLEANING AND DISINFECTING
Documents / Resources

Prior to use, carefully read the instructions for use.

FIT CHECKER TM ADVANCED BLUE

VPS SILICONE FOR CHECKING FIT AND OCCLUSAL CONTACT
For use only by a dental professional in the recommended indications.

RECOMMENDED INDICATIONS

To check the fit of dental prosthetic appliances.
• Crown: margin, proximal surface, the occlusal surface.
• Precast post: fit of the post.
• Inlay: margin, the proximal surface.
• Denture: mucosal surface.
To check occlusal contact.

CONTRAINDICATIONS

Avoid the use of this product in patients with known allergies to silicone.

PRECAUTION

When extruding or mixing FIT CHECKER ADVANCED BLUE , care should be taken to avoid mixing or contact with the following materials which may delay or prevent setting: Catalyst for condensation silicone impression materials, polysulfide impression materials, eugenol materials, sulfur, latex, oil, acrylates, glycerol, and spray-type or ointment-type topical surface anesthesia (e.g. lidocaine).

DIRECTIONS FOR USE

CARTRIDGE LOADING AND DISPENSING

Lift the release lever of CARTRIDGE DISPENSER II and pull the piston plunger all the way back into the dispenser. Lift the cartridge holder of the dispenser and load the cartridge, ensuring that the V-shaped notch on the flange of the cartridge is facing down. Push the cartridge holder down to hold the cartridge firmly in place.
Lift the release lever and push the piston plunger forward until it engages into the cartridge.
Remove the cartridge cap by rotating 1/4 turn counter-clockwise. Tilt the cap downward and peel it away from the cartridge. Gently squeeze the dispenser handle to extrude a small amount of material from the two openings at the end of the cartridge. Make sure that the base and catalyst come out evenly.
Align the V-shaped notch on the rim of the MIXING TIP II to the V-shaped notch between the cartridge barrels. Push firmly to attach the mixing tip. Then rotate the colored collar of the mixing tip 1/4 turn clockwise to the end of the cartridge. The dispenser is now ready for use.
Squeeze the handle several times to extrude the material. After use, do not remove the MIXING TIP II as this will become the storage cap until the next use. When replacing the MIXING TIP II, rotate the collar on the mixing tip 1/4 turn counter-clockwise to align the V-shaped notch on the cartridge. Tilt the mixing tip downward and peel it away from the cartridge.
Remove the old mixing tip prior to the next use. Before attaching a new tip, gently extrude a small amount of material to ensure that base and catalyst are flowing evenly from both openings. If the materials should fail to extrude, remove any hardened materials from the end of the cartridge.
To replace the cartridge, lift the release lever and retract the piston plunger fully. Remove the empty cartridge by lifting the cartridge holder and loading a new one into the dispenser.

FIT CHECKING

Apply the mixture to the internal surface of the prosthetic appliance and seat it in the mouth. Working time is 1 minute from the start of the mix at 23°C (73°F) Hold in position for 1 minute until the material is set.
Remove the prosthesis using a suitable instrument. Check the thickness of the FIT CHECKER ADVANCED BLUE to assess the fit of the prosthesis. A suitable fit is shown by being uniformly covered with a thin film. If there is a spot where the film appears to be extremely thin or thick, it should be corrected using standard techniques.
After the assessment, remove the material and clean the prosthesis.
Note: a. Do not use FIT CHECKER ADVANCED BLUE on surfaces relined with silicone-based soft relining material, as it would be difficult to remove.
b. FIT CHECKER ADVANCED BLUE is a highly flowable material. Care should be taken to ensure the material does not flow into the patient’s throat.
c. Avoid desiccation of tooth and surrounding tissue when applying FIT CHECKER ADVANCED BLUE.
d. FIT CHECKER ADVANCED BLUE has a unique chemistry that allows it to polymerize faster in the oral cavity than at room temperature. Therefore to determine the setting, examine the material in the mouth since the material on the bench will yield a false result.
e. Higher temperatures shorten the working time and lower temperatures increase working time.

OCCLUSAL CONTACT

Apply the mixture to the occlusal surface and let the patient slowly occlude. Hold in position for 1 minute until the material is set.
After FIT CHECKER ADVANCED BLUE has been set, remove the prosthesis from the mouth and assess the occlusal contacts.
Rinse the impression under running tap water and disinfect with an appropriate disinfectant.
Note: a. Block out the undercut using wax materials when taking occlusal registration of patients with orthodontic appliances.
b. When taking the occlusal registration on a model, apply a thin layer of petroleum jelly on the model or prosthesis before applying FIT CHECKER ADVANCED BLUE.

COLOR
BLUE

STORAGE
Recommended for optimal performance, store at room temperature away from direct sunlight (15-25°C, 59-77°F).

PACKAGES

FIT CHECKER ADVANCED BLUE
Two cartridge packages: Cartridge 56 g (48 mL) x 2, MIXING TIP II S x 3, MIXING TIP II SS x 3

CAUTION

In case of contact with oral tissue or skin, remove and flush with water.
In case of contact with eyes, flush immediately with water and seek medical attention.
Do not mix FIT CHECKER ADVANCED BLUE with components of any other products.
Avoid getting material on clothing as it is difficult to remove.
In case of contact with skin, remove the material after setting. If removed before setting, the material may stain your skin.
Take care to avoid ingestion of the material.
Personal protective equipment (PPE) such as gloves, face masks, and safety eyewear should always be worn.
In rare cases, the product may cause sensitivity in some people. If any such reactions are experienced, discontinue the use of the product and refer to a physician.

Some products referenced in the present IFU may be classified as hazardous according to GHS.
Always familiarize yourself with the safety data sheets available at: http://www.gceurope.com or for The Americas http://www.gcamerica.com
They can also be obtained from your supplier.

CLEANING AND DISINFECTING

MULTI-USE DELIVERY SYSTEMS: to avoid cross-contamination between patients this device requires mid-level disinfection. Immediately after use inspects the device and label it for deterioration. Discard the device if damaged.

DO NOT IMMERSE. Thoroughly clean device to prevent drying and accumulation of contaminants.
Disinfect with a mid-level registered healthcare-grade infection control product according to regional/national guidelines.
Undesired effects- Reporting:

If you become aware of any kind of undesired effect, reaction, or similar events experienced by the use of this product, including those not listed in this instruction for use, please report them directly through the relevant vigilance system, by selecting the proper authority of your country accessible through the following link: https://ec.europa.eu/growth/sectors/medical- devices/contacts_en as well as to our internal vigilance system: vigilance@gc.dental In this way you will contribute to improving the safety of this product.

Last revised: 05/2021

MANUFACTURED by
GC CORPORATION
76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japan
RESPONSIBLE MANUFACTURER IN CANADA:
GC AMERICA INC.
3737 West 127th Street, Alsip, IL 60803 U.S.A.

DISTRIBUTED by
GC CORPORATION
76-1 Hasunuma-cho, Itabashi-ku, Tokyo 174-8585, Japa
**** EU : GC EUROPE N.V.
Researchpark Haasrode-Leuven 1240, Interleuvenlaan 33,
B-3001 Leuven, Belgium TEL: +32 16 74 10 00

GC AMERICA INC.
3737 West 127th Street, Alsip, IL 60803 U.S.A.
TEL: +1-708-597-0900
www.gcamerica.com

GC SOUTH AMERICA
Rua Heliodora, 399, Santana – São Paulo, SP, BRASIL
CEP: 02022-051 – TEL: +55-11-2925-0965
CNPJ: 08.279.999/0001-61

RESP. TÉC: Erick de Lima – CRO/SP 100.866

GC ASIA DENTAL PTE. LTD.
5 Tampines Central 1, #06-01 Tampines Plaza 2, Singapore 529541
TEL: +65 6546 7588

GC AUSTRALASIA DENTAL PTY. LTD.
1753 Botany Rd, Banksmeadow, NSW 2019, Australia
TEL: +61 2 9301 8200
PRINTED IN JAPAN

Documents / Resources

| GC AMERICA Fit Checker Advanced Blue Vpes Silicone for Checking Fit and Occlusal Contact [pdf] Instructions
Fit Checker, Advanced Blue Vpes Silicone for Checking Fit and Occlusal Contact, Fit Checker Advanced Blue Vpes Silicone for Checking Fit and Occlusal Contact
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