14-11-2 英語版
Revised October 1, 2019 (Revision 12)

Identification Number: 218AABZX00035000

Controlled Medical Device - Composite Resin for Crowns and Bridges

Luna-Wing[Indications]

Metal reinforced crowns and bridges[Contraindications and Prohibitions]
DO NOT USE THIS PRODUCT ON PATIENTS WHO HAVE A HISTORY OF ALLERGY SUCH AS IRRITATION
TO THIS PRODUCT OR METHACRYLIC ACID SERIES OR METHACRYLATE MONOMER.
[Shapes, Composition and Principles]
This product consists of the following items and contains ingredients below.
Item/Composition

methacrylate monomer, inorganic fillers( silica: particle diameter<50µm ), pigments, etc.
methacrylate monomer, organic fillers, inorganic fillers( silica:particle diameter <0.5µm ), pigments, etc.
methacrylate monomer, inorganic fillers( silica: particle diameter<50µm ), pigments, etc.

Inorganic Filler
Content Rate
Approximately
37 vol%Approximately
44 vol%Approximately
38 vol%methacrylate monomer, inorganic fillers( silica: particle
diameter<50μm ), silane coupling agent, pigments, etc

Approximately
37 vol%StateOpaque Resin

Paste

Body Resin

Paste

Stain

Paste/LiquidPrimer Paste

PasteIngredients

Principles: This material is cured by visible light.

[Intended use and effect / efficacy]This product is intended to use for dental crown restoration such as facing crowns, jacket crowns, and bridges and fabricating
temporary crowns or repairing artificial crowns outside mouth.

[Product Specification]
Test method: ISO 10477
Items

Requirement ( Type 2 - Class 2 )Depth of Cure(Hardness)

Top surface: ≧ 18HV0.5
Bottom surface: not less than 70% of the top surface

Flexural Strength≧ 80 MPa

Water Sorption≦40μg/mm³Solubility≦7.5μg/mm³Curing procedure is as given in the table.
Also, when using this product under clinical conditions, please refer to the manual provided with the device you are using for
information on appropriate light levels for curing.
Please contact your dealer for more information on effective wavelengths and light levels for polymerization devices.

※Body
Resin

LED CURE Master*(1) Making Metal Framework
Make a plaster model in accordance with normal practice. Cut back and make the crown shape using wax; then apply bonding
material and retention beads on facing part to make wax pattern (mould of metal framework).
Then cast the metal following product instruction. In cases where this product is used for anterior tooth and facing crown, theocclusal area of the opposing tooth must be metal-coated to avoid fracture.
(2) Alumina Treatment of Metal Frame
Sand-blast (about 0.2~0.25MPa) the surface with alumina powder (about 50μm); then use a steam cleaner or an ultrasoniccleaner to wash, then dry.
(3) Primer Paste and Invisible Opaque Application and Light Curing
Apply Primer Paste evenly with a flat brush. Leave it for about 120 sec., to enhance bonding strength and light cure. Then apply
Invisible Opaque with a flat brush to flow into the undercut area of retention beads and light cure. Apply thinly in margin areawith no beads. Primer paste is a bonding material, but at the same time it can be used as Invisible Opaque, the use of Invisible
Opaque is not necessary. In this case, Primer Paste should be applied to cover the undercut area of retention beads.
※Primer Paste cannot be used for gold alloys.
(4) Opaque Application and Light Curing
Apply opaque thinly and light cure for about 180 sec. In cases where the metal color is visible, repeat this step until the metalcolor is concealed.
※Do not apply thickly at one time.
Use Special Opaque Color to express transparency of the incisal area or to emphasize color of the neck.
(5) Base Application and Light Curing
For pontic part, apply Invisible Opaque to pontic area and light cure for about 90 sec. then apply Base.
(6) Body Resin Application and Light Curing①Application of Cervical, Opaque Dentine and Dentine and Light Curing
Apply Cervical or Opaque Dentine starting from the neck to the incisal area, applying progressively thinner, taking subsequentcolor gradation into consideration. Light cure for about 60 sec. Then, apply Dentine to form the required dentine core shapeand light cure for about 60 sec. If partial characterization or color adjustment is necessary, apply desired color with a roundbrush and light cure for about 60 sec.
②Application of Enamel and Translucent and Light Curing
Apply Enamel to form the required crown shape and light cure for about 60 sec. In cases where Translucent is required, applyTranslucent and light cure for about 60 sec.
After final layering, light cure for about 180 sec. as a final light curing.
(7) Corrections to ShapeCorrect the shape using a carborundum or diamond point.
*Additional Layering
In cases where additional layering after correcting the shape is needed, apply bonding agent for additional layering such as
Multi Primer REPAIR LIQUID ONE, etc. thinly, then apply body resin correspondingly. Then light cure for about 60 sec.
(8) Finishing
Remove any scars with paper cone and silicon point to make the surface smooth.
(9) Polishing
Polish using a brush and fabric buff with polishing material to finish.

[Jacket Crowns][Instructions]

Items
Primer Paste
Invisible OpaqueOpaque[Facing Crown and Bridge]

Other light curing machine

About 10 sec.

About 90 sec.

About 30 sec.

About 180 sec.

Base

About 90 sec.

About 180 sec.

OthersAbout 10 sec.

About 60 sec.

Stain

About 10 sec.

About 60 sec.

Final Light Curing

About 90 sec.

About 180 sec.

※Body Resin (Cervical, Opaque Dentine, Dentine, Enamel, Translucent Enamel, Translucent, Effect and Base)*LED light curing machine from YAMAKIN

Prior to use, carefully read the instructions manual.

(1) Making Plaster Model and Resin Spacer Application
Make a plaster model in accordance with normal practice.
Apply Resin Spacer on surface, except margin area and dry. Then for easier removal of jacket crown mould, apply Resin Separator
thinly on margin area and dry.
(2) Opaque Application and Light Curing
Apply opaque thinly with a flat brush and light cure for about 180 sec. In cases where the metal color is visible, repeat this step
until the metal color is concealed.
※Do not apply thickly at one time.
(3) Body Resin Application and Light Curing①Application of Cervical, Opaque Dentine and Dentine and Light Curing
Apply Cervical or Opaque Dentine starting from the neck to the incisal area, applying progressively thinner, taking subsequentcolor gradation into consideration. Light cure for about 60 sec. Then, apply Dentine to form the required dentine core shapeand light cure for about 60 sec. If partial characterization or color adjustment is necessary, apply desired Stain color with around brush and light cure for about 60 sec.
②Application of Enamel and Translucent and Light Curing
Apply Enamel to form the required crown shape and light cure for about 60 sec. In cases where Translucent is required, apply
Translucent and light cure for about 60 sec.
After final layering, light cure for about 180 sec. as a final light curing.
(4) Corrections to ShapeCorrect the shape using a carborundum or diamond point.
*Additional Layering
In cases where additional layering after correcting the shape is needed, apply bonding agent for additional layering such as
Multi Primer REPAIR LIQUID ONE, etc. thinly, then apply body resin correspondingly. Then light cure for about 60 sec.

(5) Finishing
Remove any scars with paper cone and silicon point to make the surface smooth(6) Polishing
Polish by using a brush and fabric buff with polishing material to finish. Finally, sandblast (about 0.1～0.2MPa) the inside of thejacket crown using alumina powder (about 50μm), then use steam cleaner or ultrasonic cleaner to wash, and then dry.

[N.B.: Technical Directions and Points for Attention]
1.

2.
3.
4.
5.
6.
7.
8.
9.
10.

For light-curing this product, use a halogen lamp, xenon lamp, metal halide lamp or LED with an effective wavelength of 400500 nm.
In cases where other medical curing equipment is to be used, or if you have any questions about curing machines, please feel
free to contact us.
As fractures may happen, this product cannot be used for molars and second premolars.
In cases where this product is used for anterior tooth and facing crown, the occlusal area of the opposing tooth must be metalcoated to avoid fracture.
Close the cap promptly and tightly after using this product.
Use separate brushes for Primer Paste, Opaque, Stain and bonding agent for additional layering.
When this material is in use on a pallet or mixing paper, it should be protected by a shade cover.
Do not mix body resin with other materials, and do not mix more than one type of body resin to prevent air bubble entrappingand deterioration in quality of material properties.
Stain must be applied on internal layer; please use Enamel or other products after Stain application.
Avoid exposures to strong light or sunlight (near windows or laboratory lights, etc.) in order to prevent hardening of paste.
Do not use Base on facing part, as Base is designed only for the pontic area.

[Precautions]① Provide adequate ventilation (several times per hour) during operation.
② When cutting and polishing cured product, use exhaust fan and anti-dust mask as approved by your local public safety agency inorder to avoid inhaling dust. Wear safety goggles to protect the eyes.
③ Do not use this product outside the scope of recommended indications, effects or potency.
④ Do not use this product in combination with other products.
⑤ Only adequately certified personnel should handle this product.
⑥ Do not operate the syringe at low temperature as it may break. Please use this product at an ambient temperature of 20-25℃ isthe optimal and recommended temperature for easy handling. In cases where the product has been stored at 4℃, leave it at aroom temperature of around 20℃ for more than 20 min. in order to prepare product for use.

[Important Basic Cautions][Important Basic Cautions]① Stop using this product immediately if any signs of allergy, such as irritation or rush, appears in patients. If symptoms persist,seek medical advice.
② Operators must discontinue use if any signs of irritation or rash appear. If symptoms persist, seek medical attention.
③ Do not handle uncured material of this product with bare hands. Wear plastic gloves and safety goggles to protect from irritation.
Avoid direct skin and eye contact. In case of skin contact, wipe with alcohol cotton swab, and flush with plenty of running water.
In case of eye contact, immediately flush with plenty of running water, and consult a physician.
[Other Cautions]
Crown restoration area may be stained and plaque-adherent depending on patients’ dietary habits. Advise daily oral cleaning.

[Handling and Storage]① This product must be stored in out of contact with direct light sources at a temperature of 4-25℃.
② Do not store too many products in the same storage area.
③ Equip with a fire extinguisher in work or storage area.
④ Keep out of reach of personnel other than dental staff.

[Expiry Date]① This product must be used before the expiry date printed on the package.
② The expiry date printed on the package is based on our authentication.
③ The expiry date printed on the package refers to use expiry date.
*(ex.; YYYY-MM means the last day of YYYY ’year’/MM ’month’ as the expiry date)[Package]○ Opaque Resin･Invisible Opaque ( 2.3ml ): IvO･Opaque ( 2.3ml ): OA0, OA1, OA2, OA3, OA3.5, OA4, OB1, OB2,OB3, OB4, OC1, OC2, OC3, OC4, OD2, OD3, OD4･Special Opaque Color ( 2.3ml ): Ino1, Ino2, PO, MO○ Body Resin･Cervical 5g ( 3ml ): CA1, CA2, CB1, CB2, CC1, CC2, CD1, CD2･Dentine 5g ( 3ml ): DA0, DA1, DA2, DA3, DA3.5, DA4, DB1, DB2,DB3, DB4,
DC1, DC2, DC3, DC4, DD2, DD3, DD4･Dentine (Harmonized Shade) 5g(3ml)： DA2 HS, DA3 HS, DA3.5
HS･Opaque Dentine 5g ( 3ml ): ODA0, ODA1, ODA2, ODA3, ODA3.5,
ODA4・Opaque Dentine (Harmonized Shade) 5g(3ml)：ODA2 HS,ODA3 HS,
ODA3.5 HS･Enamel 5g ( 3ml ): E0, E1, E2, E3, E4, E0 Hard, E1 Hard, E2 Hard,
E3 Hard, E4 Hard・Enamel (Harmonized Shade) 5g(3ml)：E2 HS, E3 HS,
E2 HS Hard, E3 HS Hard･Trans Enamel 5g ( 3ml ): TE, TE Hard･Translucent 5g ( 3ml ): HVT, T, LVT, CT,
HVT Hard, T Hard, LVT Hard, CT Hard･Effect 5g ( 3ml ): HV WE, WE, AM, OC, Coffee, Orange, L Gum,Gum, D Gum･Base 5g ( 3ml ): Base
○ Stain･Stain ( 1ml ): White, Milky, Pink, Salmon Pink, White Violet, Violet,Orange, Dark Orange, Red, Yellow, Blue, Brown,
Red Brown, Dark Brown, A Shift, B Shift, C Shift,
D Shift, Gray, Black･Stain Clear ( 6ml ): Clear○ Primer Paste ( 2.3 ml )