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510(k) Data Aggregation
K Number
K250063Device Name
ARENA Star, Galaxy Star
Manufacturer
ARUM Dentistry Co., Ltd.
Date Cleared
2025-07-10
(181 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K250826Device Name
Multi M Series
Manufacturer
DMAX Co., Ltd.
Date Cleared
2025-06-12
(86 days)
Product Code
EIH, DAT
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi M Series is used in the manufacture of dental prosthesis.
Device Description
Multi M Series is zirconia-based ceramic provided in various shapes such as round and it is used to manufacture cores of all ceramic crowns and is classified into ISO 6872 Type 2 Class 5. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 278 different shades to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine. Multi M Series offers various types as follows: W-type, Z-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. Users can choose a type which fits the jig they have.
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K Number
K251084Device Name
zirkon; structure; LFU shades, stains and glazes
Manufacturer
estetic ceram ag
Date Cleared
2025-06-05
(57 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Types of restorations:
1. Anterior and posterior crowns
2. Veneers, inlays, onlays.
Device Description
zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.
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K Number
K250673Device Name
CERABIEN MiLai
Manufacturer
Kuraray Noritake Dental Inc.
Date Cleared
2025-05-29
(84 days)
Product Code
EIH, DAT
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in prosthetic dentistry to create an all-ceramic prosthesis.
- Ceramic for coverage of a zirconia substructure
- Ceramic for coverage of a lithium disilicate substructure
[CTE: 9.5~11.0×10-6/K (50-500°C)]
Device Description
CERABIEN MiLai is a specific type of porcelain for dental restorations. The system consists of Powder, Paste and Liquids for powder/paste, to be applied utilizing layering technique and baked onto a ceramic frame of zirconia (ZrO2) or different lithium disilicate glasses.
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K Number
K250534Device Name
Biomic Color Opaque
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2025-05-20
(85 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomic Color Opaque is liquid used for coloring pre-sintered zirconia restorations. It is used for the internal surface of dental zirconia material prosthesis.
Device Description
Biomic Color Opaque is a liquid primarily composed of Methylacryloyl propyl trimethoxy silane, deionized water, 1, 3-butanediol, ferric chloride, citric acid, cerium nitrate, erbium nitrate, cobaltous nitrate, manganous acetate, and aluminum nitrate.
This product is designed for use on the internal surface of dental zirconia material prostheses. It penetrates tightly with the zirconia surface, forming an extremely thin shade layer that reduces the internal surface permeability of the zirconia material prosthesis. The devices are intended to be used solely by dental technicians for the fabrication of zirconia restorations for individual dental patients.
For staining, the zirconia materials must be immersed into the staining solution or brushed with the liquid before sintering at high temperature. The staining solution consists of two components: Type I - a color component (A、B、C、D、W、L、M、R、S、X), and Type II - an OP component, 1:1 collocation is recommended. These components are mixed together for use on the zirconia material to achieve the desired shade.
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K Number
K250393Device Name
ZircaGlow & ZircaGlow HT Zirconia
Manufacturer
United Zirconia
Date Cleared
2025-05-12
(89 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZircaGlow & ZircaGlow HT Zirconia blanks are indicated for use by dental technicians for the production of full contour and substructures restorations up to a full arch.
Device Description
ZircaGlow & ZircaGlow HT Zirconia are disc and block shaped dental porcelain zirconia oxide blanks that come in various sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM). Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as a crown, bridge or coping.
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K Number
K250811Device Name
Dental Zirconia Ceramic
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2025-04-11
(25 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Zirconia Ceramic are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.
Device Description
Dental Zirconia Ceramic is pre-shaded zirconia, and it's composed of yttria-stabilized zirconia. It contains ZrO2+HfO2+Y2O3+Al2O3 and very small amount of additional inorganic pigments (Fe2O3+Er2O3+Co3O4). The inorganic pigments generate the color on the restorations, after sintering at dental labs, that matches natural color of patient's teeth.
Dental Zirconia Ceramic has 19 models mainly according to the flexural strength (i.e. ≥600Mpa and ≥800Mpa) and the shade uniformity in the whole blank (i.e. monolayer and multilayer). Each model also has several available shade variations. And it also offers various shapes and dimensions suitable for different milling systems.
The proposed device is processed into the dental restorations such as crowns, bridges, veneers, inlays and onlays based on the anatomical rendering of the patient's teeth using CAD/CAM (computer aided design / computer aided manufacturing) method or manual milling method.
The proposed device is a single-use device, provided non-sterile, and its performance conforms to ISO 6872:2015/AMD 1:2018 Dentistry: Ceramic Materials.
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K Number
K250025Device Name
Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2025-03-14
(67 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.
Device Description
This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.
Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:
Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.
Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing
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K Number
K250223Device Name
BruxZir® Esthetic NOW
Manufacturer
Prismatik Dentalcraft, Inc.
Date Cleared
2025-02-25
(29 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BruxZir® Esthetic NOW is used for dental restorations using different CAD/CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.
Device Description
BruxZir® Esthetic NOW is a chairside zirconia material offering enhanced esthetic performance. These pre-shaded, fully sintered zirconia CAD/CAM blocks are used by dentists in the construction of custom-made dental restorations that require no sintering, staining, glazing or polishing.
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K Number
K243940Device Name
VITA YZ Multi Translucent
Manufacturer
Vita Zahnfabrik H.Rauter GmbH & Co.
Date Cleared
2025-02-21
(63 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Product Code :
EIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VITA YZ MULTI TRANSLUCENT is indicated for:
- · fully anatomical anterior and posterior crowns
- · fully anatomical 4 unit anterior and posterior bridges
- · fully and partially veneered single tooth and up to 4-unit bridge substructures in the anterior and posterior tooth regions
- · inlays
- · Onlays
- · veneers
Device Description
VITA YZ MULTI TRANSLUCENT are zirconia blanks for reliable shade reproduction. They can be used for the production of fully and partially veneered reconstructions and monolithic bridge restorations in the anterior and posterior tooth regions. VITA YZ MULTI TRANSLUCENT is part of the VITA YZ SOLUTIONS product group.
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