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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)

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).

The provided text describes Dental Direkt GmbH's K230218 510(k) submission for "DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (K191111).

The document does not describe a study that uses a test set, expert readers, or AI performance metrics. Instead, it focuses on demonstrating substantial equivalence through a comparison of the subject device with a predicate device, relying on material, manufacturing, and general design similarities, along with performance testing according to established standards for dental implants.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document as it pertains to a different type of device evaluation (substantial equivalence based on physical and functional comparison to a predicate, rather than an AI/software performance study).

The "Performance data" section (Page 4, last entry of the large table) explicitly states:

• "Fatigue testing according to ISO 14801 [FDA Recognition #4-195] and FDA guidance for Industry and FDA Staff Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004."
• "No new biocompatibility testing: Biocompatibilty testing for cytotoxicity according to ISO 10993-5 [FDA Recognition #2-245] leveraged from Predicate Device K191111 (worst case series)."
• "No new sterilization validation: Sterilization validation according to ISO 17665-1 [FDA Recognition #14-333], ISO 11737-1 [FDA Recognition #14-577] and ISO 11737-2 [FDA Recognition #14-540] leveraged from Predicate Device K191111 (worst case series)."
• "Reverse engineering dimensional analysis was conducted using OEM implant bodies, OEM abutments, and OEM abutment screws."

This indicates that the performance evaluation relies on bench testing (fatigue), leveraging existing biocompatibility and sterilization data from the predicate device, and dimensional analysis, not on clinical studies involving test sets, human readers, or AI.

In summary, the provided document does not contain the information required to answer the prompt as it pertains to AI/software performance studies. The device is a physical dental abutment, and its clearance is based on substantial equivalence to a predicate device through engineering and material comparisons and standardized physical testing.

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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.

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).

The provided text is a 510(k) summary for a dental device (DD Solid Connect® CAD/CAM Abutments). It details the device's indications for use, technical characteristics, and a comparison to predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/Machine Learning component with acceptance criteria, expert ground truth, or MRMC studies.

The "Performance data" section refers to:

• Fatigue testing according to ISO 14801 and FDA guidance for dental implants/abutments. This is mechanical testing to assess durability.
• Biocompatibility testing for cytotoxicity according to ISO 10993-5. This assesses the material's safety in contact with biological systems.
• Sterilization validation according to ISO 17665-1, ISO 11737-1, and ISO 11737-2. This verifies the sterilization process.
• Reverse engineering dimensional analysis using OEM implant bodies, OEM abutments, and OEM abutment screws. This is to ensure compatibility and fit.

These are standard engineering and biocompatibility tests for medical devices, not performance studies for AI/ML algorithms predicting or classifying medical conditions.

Therefore, I cannot extract the requested information (acceptance criteria, details of an AI/ML study, sample sizes for AI/ML test/training sets, expert ground truth, MRMC studies, or standalone performance) from the provided text as it pertains to the approval of a physical dental abutment and not an AI/ML diagnostic or predictive device.

Ask a specific question about this device