estetic ceram ag 0483 EMF-Bonder Instructions

estetic ceram ag 0483 EMF-Bonder

Product Information: EMF-Bonder

The EMF-Bonder is a leucite glass ceramic containing opacifiers and reactive pigments. It is designed for dental applications and should only be used by trained professionals. The product has specific indications and contraindications, which should be followed for safe and effective use.

Indication
The EMF-Bonder can be used for dental applications with approved framework materials and within the range of product systems described by estetic ceram. It is suitable for use in dental restorations made of glass ceramics.

Contraindication
The EMF-Bonder should not be used in combination with ceramic materials outside of estetic ceram’s described range of product systems or with non- approved framework materials. It should not be used on sharp edges and corners of the framework or non-anatomically reduced frame shapes. The product is not recommended for patients with bruxism or parafunction.

Framework Fabrication
The metal framework must be prepared according to the  manufacturer’s instructions, with a reduced anatomical shape that  provides enough space for an even coating of layering ceramic < 2 mm. Sharp edges and corners need to be rounded off before applying the EMF-Bonder. The framework must be cleaned thoroughly before any porcelain application.

Application
The EMF-Bonder is offered in paste form or as powder in cans. The paste has a ready-to-use consistency and can be applied as a covering layer that does not run off. The powder must be mixed with estetic ceram opaque liquid to a paste-like consistency. The product should be applied to the well-cleaned, dry framework in a thin, even layer using a brush or a glass instrument.

Firing Chart
The firing chart provides approximate firing temperatures and parameters for the EMF-Bonder. Corrections to the firing temperatures may be necessary for other furnace types.

Technical Data
The EMF-Bonder Classic 920 complies with all applicable standards for dental porcelains (DIN EN ISO 6872), with limits  undercut and thresholds outperformed.

Regulatory Information
The EMF-Bonder is a product of estetic ceram ag and is intended for dental use only.

Warnings, Label Symbols, Manufacturer Information
The product should be used only by trained professionals and according to the manufacturer’s instructions. The product has specific indications and contraindications that should be followed for safe and effective use. The product should be stored in a cool, dry place and protected from light. The use of personal protective equipment is recommended when handling the product.

Product Usage Instructions: EMF-Bonder

1. Prepare the metal framework according to the manufacturer’s instructions, with a reduced anatomical shape that provides enough space for an even coating of layering ceramic < 2 mm. Round off any sharp edges or corners.
2. Clean the framework thoroughly before applying the EMF-Bonder.
3. Apply the EMF-Bonder to the well-cleaned, dry framework in a thin, even layer using a brush or a glass instrument.
4. If using the paste form of the product, dry the brush with water after washing out and then moisten with opaque liquid before applying.
5. If using the powder form of the product, mix it with estetic ceram opaque liquid to a paste-like consistency before applying.
6. Bake the framework according to the firing chart provided, making any necessary corrections for other furnace types.
7. After the bonder firing, the EMF-Bonder will have a yellowish color and an eggshell luster. Apply the opaque as usual.

The estetic ceram EMF-Bonder is a leucite glass ceramic and contains opacifiers and reactive pigments. EMF-Bonder is only intended for dental applications and for use by trained professionals.

Indication

• EMF-Bonder creates an intermediate layer between Chromium-Cobalt based alloys and the veneering porcelain for the reconstruction of natural looking teeth in the form of metal ceramic crowns or bridges on Chromium-Cobalt alloys with a thermal expansion of 14 – 15×10-6×K-1 (25 – 500° C).

Contraindication

• Combinations with ceramic materials outside of estetic ceram’s described range of product systems and/or material from another manufacturer.
• Use of non-approved framework materials.
• Sharp edges and corners on the framework or non-anatomically reduced frame shapes.
• Dental ceramic and complete ceramic restorations made of glass ceramics are not recommended for patients with bruxism or parafunction.

Framework Fabrication

prepared CoCr-metal framework

The fabrication of metal framework (casting, processing, cleaning/oxidation) must be performed according to the manufacturer’s instructions. The framework must have a reduced anatomical shape and should provide enough space for an even coating of layering ceramic < 2 mm. Sharp edges and corners need to be rounded off.

Important note: Cleaning of framework before any porcelain application.
Base metal alloys (Cobalt-Chromium and Nickel-Chromium) create water-soluble chromium oxides during every heat treatment process. The oxide must be removed before porcelain application. Clean the framework and the layering with steam or water and brush thoroughly before another porcelain application.

Application

The estetic ceram EMF-Bonder can be used with non-precious metal alloys and reduces the problems of strong oxide formation (green discolouration and flaking of the ceramic). The EMF-Bonder serves as an intermediate layer between cobalt-chromium-based ones Dental alloys and dental ceramics for the reconstruction of metal-ceramic crowns and bridges on cobalt-chrome alloys with a thermal expansion of 14 – 15 × 10-6 × K-1 (25 – 500 °C).
The EMF-Bonder is offered in paste form or as powder in cans. The paste has a ready-to-use consistency and can be applied as a covering layer that does not run off.
The powder must be mixed with estetic ceram opaque liquid to a paste-like consistency.
Please note with all pastes: Water acts as an extreme diluent for the pastes, so please dry the brush for the pastes with water after washing out, and then moisten with opaque liquid before applying.
Apply the EMF-Bonder with a brush or a glass instrument to the well-cleaned, dry framework in a thin, even layer.

CoCr-metal framework before bonder bakE

CoCr-metal framework after bonder bake

Bonder Bake
After the bonder has been applied, the restoration is dried under the open oven at a starting temperature of 450 °C for 1-2 minutes. The furnace is then closed with a closing time of 6 minutes and at 80 K/min and vacuum (vacuum on at 450 °C) heated to 980 °C. Holding time: 6 minutes (without vacuum).

After the bonder firing, the EMF-Bonder shows a yellowish colour and an eggshell luster. Then the opaque is applied as usual.

Firing Chart

Note: The below given firing temperatures were determined in a Zubler Vario 300 dental furnace and are approximate values. For other furnace types, corrections to the firing temperatures may be necessary.

Firing parameters

| Start temperature [ °C ]| Closing time [ min ]| Vacuum start [ °C ]| Heating rate [ K/min ]| (Vacuum end) 1st Bake
[ °C ]| (Vacuum end) 2 nd Bake [ °C ]| (Without vacuum)

Holding time

[ min ]
---|---|---|---|---|---|---|---
EMF-Bonder| 450| 6| 450| 80| 980| —| 6

Technical Data

Classic 920 comply to all applicable standards for dental porcelains (DIN EN ISO 6872). All limits are undercut and thresholds are outperformed.

Materials classification

Material:| Silicate glass ceramics
Chemical composition:| Mayor glass ceramic constituents: SiO2, Al2O3, K2O, Na2O, CaO, B2O3

opacifiers (TiO2, SnO2) reactive pigment

Physical-chemical properties acc. to DIN EN ISO 6872:2019

Type:| 1      2| Class:| 1    2  3| a b c

Physical-chemical properties acc. to DIN EN ISO 6872

Property| Specification
Coefficient of thermal expansion (25 – 500 °C) [·10 -6 ·K -1 ± 0.5]| 2 ×: 11.0
4 ×: 11.0
Transformation temperature Tg [°C ± 20]| 2 ×: 550
4 ×: 550
Solubility [µg/cm²]| < 2000*

• applicable limit acc. classification 2b/3b/4b DIN EN ISO 6872, because of no direct contact with oral mucosa and full covering with dental porcelain

Regulatory Information

EMF-Bonder meets all requirements of applicable medical device regulations for medical devices and the manufacturing is certified acc. ISO 13485 and annex 2 of MDD 93/42 EWG, annex IX, chap. 1 of regulation (EU) 2017/745 .

• Medical device classification acc. annex IX, rule 8 of MDD 93/42: IIa
• Medical device classification acc. annex VIII, rule 8 of MDR 2017/745 IIa
• UMDNS Code: 16 187 Dental ceramics
• MDR Code acc. MDCG 2019 14: MDT 2003, MDN 1103
• Classification acc. DIN EN ISO 6872: type 1, class 1

Warnings
Use only by trained specialists.
Wear protective goggles or suitable face protection when finishing the ceramic restorations. Remove splinters and dust with a suction device or wear a suitable dust mask.

Be careful with the high temperatures when burning. There is a risk of burns! Use oven tongs / tweezers and gloves!
Use only in a clean work environment! Contamination of the aids (waxes) and devices (mixing plate, preheating furnace) through residues from alloy processing, especially CoCr or NiCr alloys, can lead to discoloration of the ceramic.
Noble metal-free alloys based on cobalt-chromium or nickel-chromium form water-soluble oxides with every fire, which must be removed from the ceramic mass before each application. The framework or framework that has already been veneered must be cleaned thoroughly with steam or under running water with a brush before each ceramic application.
There are different firing conditions due to the different ceramic furnaces on the market. This fact must be taken into account and clarified by the customer on his own responsibility!
The specified firing temperatures are only guide values!
Recommended storage conditions: 12-38 °C and normal humidity 40-60%. Store in tightly closed original containers. Protect from direct sunlight. Do not put mixed powders back into the can. Use clean, dry instruments for removal.

Label Symbols

• Manufacturer
• Date of manufacture YYYY MM
• Medical Device
• Batch code /LOT number
• Reference number
• Unique Device Identification
• Caution, consult instruction for use

Manufacturer Information

estetic ceram ag
Landstrasse 109
9495 Triesen
Principality of Liechtenstein
Tel: +423 237 48 58
Fax: +423 237 48 59
info@esteticceram.com

estetic ceram ag
www.esteticceram.com

References

• Home | esteticceram.com
• Home | esteticceram.com

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