英語版 18-01
Revised 2019/12/05 (Revision 2)

Identification Number: 229AABZX00114000

Controlled Medical Device - Resin Material for Dental Milling and Machining

KZR-CAD HR BLOCK3GAMMATHETA[Indications]

Inlay, onlay and crowns[Contraindications and Prohibitions]

DO NOT ATTEMPT TO USE FOR PURPOSES OTHER THAN INTENDED USE.
DO NOT USE THIS PRODUCT ON PATIENTS WHO HAVE A HISTORY OF ALLERGY SUCH AS IRRITATION
TO THIS PRODUCT OR TO METHACRYLIC ACID SERIES OR METHACRYLATE MONOMER.

[Shape, Composition and Principles]
1. ShapeBlock

Holder (mounting device)(a) width1214.5(Dimensions: approx. mm)(b) height(c) depth
141814.5
18

2. Shades: A2, A3, A3.5

Cured Material*1 Diamond Polishers
・C&B Diamond Polisher
・C&B Nano Diamond Polisher*2 Composite Resin for Crowns and Bridges
・Luna-Wing
・TWiNY*3 Surface preparation agent containing Silane Coupling Agent・Multi Primer Repair Liquid One

(1)
(2)
(3)
(4)

ca

3. Composition
State[Related Prodcuts][Precautions]bType
MediumLarge

Form axial surface with thickness of 1.3 mm and over for premolars and 1.5 mm and over for molars. Also, the corners should be rounded.
4. Since the block is recessed 0.5 mm from the bonding surface with the holder (a mounting device), if the support pin is arranged in thisrecessed position, the workpiece may be detached during cutting. Pay attention to the arrangement of the support pins.
5. Sandblast (at about 0.2 to 0.3 MPa) the adhering surface of dental restorations using alumina powder (about 50 μm). After trial fitting,clean the adhering surface with phosphoric acid etching solution, and wash and dry to remove any inhibitor of adhesion such as protein
substances contained in salvia. However, when sandblasting is performed after trial fitting, cleaning with phosphoric acid etchingmaterial and etc. is unnecessary.
6. For the adhering surface of the restorations, surface treatment using a surface preparation agent containing a silane coupling agent isrequired.
7. After drying, use suitable resin cement considering adhesiveness, color tone, and transparency with abutment material.
8. When using resin cement material, follow the instruction manual provided.
9. Do not use glass ionomer-based resin cement to bond this product.

Ingredients
Methacrylate monomer, inorganic fillers, pigments, etc.

4. Principle
This product is a resin-based block to be cut or milled with a dental computer-aided design and manufacturing unit for fabricating
dental restorations such as inlays or crowns.

Only adequately certified personnel should handle this product.
Do not use this product for any purposes other than those indicated under [Intended use and effect / efficacy].
Use this product only for computer-aided dental design and for manufacturing units which fit the size of this product.
In cases where risk of fracture due to malocclusion or bruxism is high, decide carefully whether or not to use this product, so as to avoid
product fracture.
(5) During milling and polishing of cured product, use local exhaust fan and anti-dust mask as approved by your local authority to avoid
inhaling dust.
(6) Wear safety goggles to protect the eyes while milling and polishing this product.
(7) Dentists should determine whether this product is suitable for use in each individual case(8) Follow applicable local ordinances and regulations when discarding this product.
(9) Do not use or store this product near naked flame.
(10) Remove excess cement after fixing restoration.

[Important Basic Cautions](1) Stop using this product immediately in cases of any signs of allergy such as irritation or rash appearing in patients. If symptoms
persist, seek medical advice.
(2) Stop using this product immediately in cases of any signs of allergy such as irritation or rash appearing in product users. If symptoms
persist, seek medical advice.
[Other Cautions]
Advise daily oral cleaning for patients, since the fixed restoration may be stained or plaque-adherent depending on patients’ dietaryhabits.

[Intended use and effect/efficacy][Storage and Validity Period]

This product is a material to be cut or milled with a dental computer-aided design and manufacturing unit for fabricating polymeric
restorations for dental use.

〔Storage〕
・Store in a cool and dry place, avoiding high temperatures, humidity and direct sunlight.
・Keep out of reach of personnel other than dental staff.
〔Validity Period〕
・Use before the expiry date stated on the package.
・The expiry date is authenticated by YAMAKIN using our company data.
・The expiry date indicates the final deadline for its use.
(e.g. YYYY-XX means that the expiry date is the end of month of XX of YYYY year.)[Instructions](1) Measure an abutment tooth model using a scanning machine.
(2) Create milling data based on measurement data, using software.
(3) Set up this product in a milling machine and process it using milling data. After completion of processing, eliminate surplus
residue. Remove sawdust and other dust from the restoration.
(4) Correct the shape and polish in accordance with normal practice. As a final polishing, polish it with a polishing material*1 toglaze.
(5) In cases where additional layering or characterizing after milling is needed, follow the instructions for the dental resin used forcrowns and bridges*2. Surface treatment with a surface preparation agent containing silane coupling agent*3 is required before
additional layering,[N.B.: Technical Directions and Points for Attention]
1. When using CAM software or milling machine, follow the instruction manual provided for each device and ensure the appropriate
processing conditions for this product.
2. Form the margin area in deep chamfer or round shoulder and the thickness should be 0.8 mm and over for premolars and 1.0 mm
and over for molars.
3. Form pit-and-fissure with thickness of 1.0 mm and over for premolars and 1.5 mm and over for molars. Form cusp with thicknessof 1.3 mm and over for premolars and 1.5 mm and over for molars.

[Package Contents]
1 pc. per box ( A2, A3, A3.5)
5 pcs. per box ( A2, A3, A3.5)