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510(k) Data Aggregation

    K Number
    K241579
    Device Name
    DD Hybridlayer (multicolored zirconia)
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2024-09-06

    (95 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Direkt zirconium dioxide milling blanks are intended for the fabrication for long-term use.
    Device Description
    The product is not delivered sterile and cleaning, re-processing or sterilization by the user is not required. The individual variants are available in six heights (12 mm, 16 mm, 25 mm and 30 mm) to meet customer requirements. To achieve the appearance of natural tooth, the raw materials are partially mixed with a coloring of the blank. The variants of the Nacera® Pearl Natural have a color gradient from light (occlusal) to dark (tooth neck) within the blank. In this way, the color gradient of the natural tooth is reproduced.
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    K Number
    K230410
    Device Name
    DD medical polymers (PMMA)
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2023-06-23

    (128 days)

    Product Code
    EBI, MQC
    Regulation Number
    872.3760
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DD base P HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. DD base P HI is suitable for long-term use in the oral cavity up to 10 years. DD Bio Splint P HI are transparent dental milling blanks out of PMMA for the manufacture of splints, therapeutic splints and bite requlators for long-term application in the oral cavity up to 12 months.
    Device Description
    DD medical polymers (PMMA), made from PMMA, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of bite splints (clear variant) or denture bases (gingiva-colored variants) on dental CAD/CAM systems.
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    K Number
    K230218
    Device Name
    DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2023-04-25

    (89 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, Dentsply Implants Astra Tech OsseoSpeed 3.5mm implant bodies, Dentsply Implants Xive 3.4mm implant bodies, Straumann Bone Level 3.3mm implant bodies, Zimmer Biomet 31 Certain 3.4mm implant bodies and Zimmer Dental Tapered Screw-Vent 3.5mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are to be sent to a Dental Direkt validated milling center for manufacture. Compatible Implant Systems: - Altatech: Camlog (3.3, 3.8, 4.3, 5.0) - Nobel Biocare: Nobel Active (3.5, 4.3/5.0) - Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0) - Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5) - Straumann: Bone Level (3.3, 4.1/4.8) - Straumann: SynOcta (4.8, 6.5) - Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7) - Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0) - Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4) - Zimmer Biomet 3i: Certain (3.4, 4.1/5.0)
    Device Description
    The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) consist of the following parts: DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) are designed and made to individually fit the individual requirements for each patient. DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants: - Altatech: Camlog (3.3, 3.8, 4.3, 5.0) - Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP) - Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0) - Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0) - Straumann: Bone Level (3.3, 4.1/4.8) - Straumann: SynOcta (4.8, 6.5) - Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7) - Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5) - Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4) - Zimmer Biomet 3i: Certain (3.4, 4.1/5.0) The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock) are used as part of a two piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment. All two implant components, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw).
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    K Number
    K191111
    Device Name
    DD Solid Connect® CAD/CAM Abutments
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2023-01-11

    (1356 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DD Solid Connect® CAD/CAM Abutments are used to support prosthetic restorations in combination with endosseous dental implants in the upper and/or lower jaw. All digitally designed custom abutments for use with DD Solid Connect® CAD/CAM Abutments are to be sent to a Dental Direkt validated milling center for manufacture. DD Prefab abutments, for the Zimmer Biomet 3i Certain 3.4mm implant bodies, and DD Ti-Base 2CUT abutments, for the Altatech Camlog Screw-Line 3.3mm implant bodies, are indicated for maxillary lateral and mandibular central/lateral incisors only.
    Device Description
    The DD Solid Connect® CAD/CAM Abutments consist of the following parts: DD Prefab, DD Ti-Base 2CUT and DD Ti-Base 2CUT noLock. The DD Solid Connect CAD/CAM Abutments are designed and made to individually fit the individual requirements for each patient. DD Prefab attach directly to the following dental implants: - Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0) - Nobel Biocare: Nobel Active (3.5 NP, 4.3/5.0 RP) - Nobel Biocare: Replace Select Tapered (3.5, 4.3, 5.0) - Dentsply Implants: Astra Tech OsseoSpeed (3.5/4.0, 4.5/5.0) - Straumann: Bone Level (3.3, 4.1/4.8) - Straumann: SynOcta (4.8, 6.5) - Zimmer Dental: Tapered Screw-Vent (3.5, 4.5, 5.7) - Dentsply Implants: Xive (3.4, 3.8, 4.5, 5.5) - Dentsply Implants: Astra EV (3.6, 4.2, 4.8, 5.4) - Zimmer Biomet 3i: Certain (3.4, 4.1/5.0) DD Ti-Base 2CUT / DD Ti-Base 2CUT noLock attach directly to the following dental implants: - Altatech: Camlog Screw-Line (3.3, 3.8, 4.3, 5.0) The DD Prefab blanks are prefabricated components for the metal-cutting production of individualized and one-piece abutments using CAD/CAM technology. The Ti-Bases (DD Ti-Base 2CUT / DD Ti-Base 2CUT no-Lock) are used as part of a two piece abutment, where the base is premanufactured from titanium alloy (Ti-6Al-4V ELI) and the top half is a CAD-CAM zirconia superstructure, milled at a validated milling center. These pieces are cemented together to form the final abutment. All three implant components, the DD Prefab, the DD Ti-Base 2CUT and the DD Ti-Base 2CUT noLock are delivered each with an implant screw (DD Implant screw).
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    K Number
    K193588
    Device Name
    DD Contrast
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2020-04-16

    (115 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DD contrast® veneering ceramics system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.
    Device Description
    DD contrast veneering ceramics are dental ceramics for the esthetic individualization of crowns and bridges made from zirconia or lithium disilicate. The DD contrast group consists of various ceramic veneering pastes (already pre-mixed) for coloring, texturing and glazing as well as liquids for adjusting the textures of the paste variants. The DD contrast products are applied to the sintered zirconium dioxide or lithium disilicate restoration and fired in a standard furnace for veneering ceramics. Due to the different consistencies, the pastes can be used to achieve thin shade and glaze layers as well as structure-building areas on the crowns. The veneering ceramics are of type I, class 1b) according to ISO 6872 (FDA Recognition Number 4-251).
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    K Number
    K183569
    Device Name
    DD cube ONE ML
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2019-02-14

    (55 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.
    Device Description
    DD cube ONE ML are dental milling blanks made of yttria-stabilized pre-sintered zirconium dioxide, showing a super high translucency and a high strength and fracture toughness at the same time. The ceramics are of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-223). The material is suited ideally for crowns and bridges for both, the anterior and posterior region.
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    K Number
    K170885
    Device Name
    DD cubeX2 HS
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2017-08-01

    (127 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    Dental Direkt GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K153490
    Device Name
    DD medical polymers
    Manufacturer
    DENTAL DIREKT GMBH
    Date Cleared
    2016-05-13

    (161 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL DIREKT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DD medical polymers are indicated for temporary (≤ 12 months) crowns, bridges and bite splints. Applications include both anterior and posterior structures.
    Device Description
    DD medical polymers, made from medical grade, are industrially polymerized, pre-colored or clear dental milling blanks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints (clear variant) on dental CAD/CAM systems.
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    K Number
    K150196
    Device Name
    DD cubeX2
    Manufacturer
    DENTAL DIREKT GMBH
    Date Cleared
    2015-03-26

    (56 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    DENTAL DIREKT GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental blanks made from DD cubeX2 are indicated for crowns, multi-unit bridges (up to a maximum of 3 elements) and inlay bridges. Applications include both, anterior and posterior bridges.
    Device Description
    DD cubeX2 is a semi-finished dental blank made of yttrium stabilized pre-sintered zirconium dioxide, which has a super high translucency. The ceramics is of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-178). The DD cubeX2 dental blanks are designed for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or hand-operated copy milling machines. The material is suited ideally for bridges up to 3 elements for both, the anterior and posterior region. The accessories comprises the DD Bio ZX2 monolith zero, which is a coloring fluid for zirconia restorations made from yttrium stabilized pre-sintered zirconium dioxide of different degree of translucency.
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