(84 days)
The Lava software is used with 3M ESPE's Lava system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges.
The software controls the measuring process, processing of the measurement data (3D-CAD tool), and export of the data to the milling machine. In addition, various patient and case information elements can be entered. Other functions are available for verification and service of the measuring system.
The Lava software also facilitates the transfer of 3D data from a scanner to a remote milling machine via internet.
The Lava™ software is used with 3M ESPE's Lava™ system, an all-ceramic system for the CAD/CAM fabrication of dental restorations such as inlays, onlays, veneers, crowns and bridges. The Lava software controls the measuring process, editing of the measurcment data (CAD), and export of the data to the milling machine. A software module of the Lava satellite scanner facilitates the transfer of 3D data (plain scan data or fully modeled data) to the remote milling machine via internet by a secured internet connection.
The provided text does not contain any information about acceptance criteria, device performance, or a study conducted to prove the device meets acceptance criteria.
The document is a 510(k) summary for a software device called "Lava software." It primarily focuses on:
- Administrative details: Submitter information, contact details, establishment registration.
- Device identification: Name, classification, common name, predicate device.
- Device description: How the software works within the Lava™ system for CAD/CAM fabrication of dental restorations (controlling measuring, editing data, exporting to milling machine, and facilitating 3D data transfer).
- Regulatory communication: An FDA letter confirming substantial equivalence to a predicate device, outlining regulatory compliance requirements, and allowing the device to be marketed.
- Indications for Use: A formal statement of the software's intended use.
Therefore, I cannot provide the requested table and study details because the information is not present in the input.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)