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510(k) Data Aggregation
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?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
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
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?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
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?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
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
K242884Device Name
Additively Manufactured Denture Resin
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2024-11-22
(60 days)
Product Code
EBI
Regulation Number
872.3760Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Additively Manufactured Denture Resin is a light-cured resin indicated for the fabrication of all types of denture bases, for instance full and partial removable dentures.
Additively Manufactured Denture Resin is intended for continuous use in the oral environment, exclusively for professional dental work.
Additively Manufactured Denture Resin can be used in combination with a DLP 3D printers utilizing wavelengths at 385nm or 405nm. A 3D-printer is not part of the device.
Device Description
Additively Manufactured Denture Resin is a light-cured one-component materials for dental professional use only and intended for the fabrication of full and partial removable dentures. This Product is a liquid photo-curable material that is polymerized, by the photo-initiator contained in the resin. For use in Digital Light Processing (DLP)-3D printers utilizing wavelengths at 385nm or 405nm. The specifications of this product are divided into 500g, 1000g, 5kg and 10kg according to the weight of the resin liquid.
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K Number
K241715Device Name
Dental Glass Ceramics Blocks (HT,LT,ST)
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2024-07-12
(28 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Glass Ceramics Blocks are indicated for fabricating all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/ CAM system.
Device Description
Dental Glass Ceramics Blocks are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all-ceramic restorations such as veneers, inlay/ onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li2O, K2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. It has three model: HT,LT,ST, and totally 23 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2, C3,C4,D2,D3,D4,BL1,BL2,BL3,BL4, OM1, OM2 and OM3).
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K Number
K223477Device Name
PMMA Blocks for Dental Use
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2023-02-16
(90 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
Device Description
The PMMA Blocks for Dental Use is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 39 specifications for Cylinder model (variation in different diameters and heights), and 44 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 20 various shades of the proposed device: 1 is transparent (without color added), the other 19 shades are colored (with different coloring matters added). The 19 shades created based on 19 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and OM1,OM2,OM3.
The PMMA Blocks for Dental Use would be produced on the 39 specifications of Cylinder model or 44 specifications of Cuboid model, with a shade chosen from the 20 various shades.
The PMMA Blocks for Dental Use is provided as non-sterile.
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K Number
K222626Device Name
Dental Zirconia Ceramic
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2022-12-06
(97 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
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 (Fe203+Er2O3+C03O4). 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 six 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 Dentistry: Ceramic Materials.
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K Number
K213570Device Name
Dental Zirconia Ceramic
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2022-01-07
(58 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
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 thought dental laboratories or by dental professionals.
Device Description
The subject device, Dental Zirconia Ceramic, are derived from dental porcelain powder that has been processed into their final net shapes. These blanks are then being further fabricated (using hot press or CAD/CAM technologies) into all ceramic restorations such as veneers, inlay/ onlay, partial crowns,anterior crowns, posterior crowns. The ceramics material is composed of ZrO2, Y2O3 Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface, totally 16 colors(A1,A2,A3,A3.5,A4,B1,B2,B3,B4,C1,C2,C3,C4,D2,D3,and D4), with the addition of very small amount ( < 0.5 % ) of inorganic pigments: Fe2O3 +Er2O3+C0304.
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K Number
K190217Device Name
Aidite PMMA
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2020-12-17
(682 days)
Product Code
EBG
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.
Device Description
The Aidite Pmma is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.
The proposed device contains two models with different shape: Cylinder and Cuboid. There are 40 specifications for Cylinder model (variation in different diameters and heights), and 24 specifications for Cuboid model (variation in different lengths, widths, and heights).
There are 17 various shades of the proposed device: 1 is transparent (without color added), the other 16 shades are colored (with different coloring matters added). The 16 shades created based on 16 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.
The Aidite Pmma would be produced on the 40 specifications of Cylinder model or 24 specifications of Cuboid model, with a shade chosen from the 17 various shades.
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K Number
K192723Device Name
Coloring Liquid
Manufacturer
Aidite (Qinhuangdao) Technology Co., Ltd.
Date Cleared
2020-08-18
(326 days)
Product Code
EIH
Regulation Number
872.6660Why did this record match?
Applicant Name (Manufacturer) :
Aidite (Qinhuangdao) Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.
Device Description
Coloring liquid are water-based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperature.
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