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The Lava™ system is intended for CAD/CAM fabrication of all-ceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Lava™ Frame and Lava™ Frame Shade are intended for the manufacturing of abutments.

The titanium connection for the abutment must meet the following dimensions:

• Overall cementation surface > 30 mm²
• Height of the head of the titanium interface from the shoulder > 2.8 mm

The following systems fulfill the above described specifications:

Co. Alitec Dental GmbH: Camlog Titanium base for Ceramic abutment. Abutment ø ≥ 4.3 mm

• Co. Alltec Dental GmbH: Camlog Titanium-base for Ceramic-abutment - Abutment a ≥ 4.3 mm

• Co. Dentsply Friadent GmbH: Friadent Cera Base

• Co. Neoss GmbH: Neo Link Neoss Mono Abutment Titanium; Neo Link Neoss Multi Abutment Titanium; Neo Link Neoss Mono Aesthetic Abutment Titanium; Neo Link Neoss Multi Aesthetic Abutment Titanium; Matrix Abutment Hex - Regular Mono Titan; Matrix Abutment Hex - Regular Multi Titan; Matrix Abutment Hex - Narrow Mono Titan; Matrix Abutment Hex - Narrow Multi Titan; Matrix Abutment C-Lect - Regular Mono Titan; Matrix Abutment, C-Lect - Regular Multi Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment C-Lect - Narrow Mono Titan; Matrix Abutment ST - Mono Titan; Matrix Abutment ST - Mono Titan

Lava™ abutment made from Lava™ Frame zirconia mill blanks and dyed with Lava™ Frame Shade is classified as cndosseous dental implant abutment (21 C.F.R. § 872.3630) because it is a prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Lava™ Frame and Lava™ Frame Shade are parts of the Lava™ system (K011394). Lava™ Frame Zirconia mill blanks are used for the fabrication of frameworks for allceramic restorations. The frameworks for onlays, inlays, veneers, crowns and bridges are designed and manufactured by CAD/CAM technology, whereas the CAM fabricated Lava™ Abutments made from Lava™ Frame Zirconia mill blanks will be designed by means of a traditional wax up technique. The wax up will be scanned (Lava™ Scan, K062493) and milled without any further design step in the CNC milling unit Lava™ Form. After milling, the abutments are dyed with one of the 7 Lavat 10 Frame Shade dyeing liquids as required to achieve the desired tooth color, then sintered. The dyed abutments are sintered using the specialized program of the Lava™ Therm sintering furnace.

The wax up designed abutment will be cemented to a titanium interface which will be subsequently screwed into the respective implant (e.g. Camlog, Altatec Biotechnologies).

The provided text is a 510(k) Summary and FDA clearance letter for a dental device called "Lava™ Frame, Lava™ Frame Shade." This document describes the device and its intended use, but it does NOT include any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods.

Therefore, I cannot fulfill your request for that specific information based on the text provided. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a device's performance against specific acceptance criteria.

The 510(k) summary only states: "In summary, it can be concluded that safety and effectiveness requirements for Laya™ Frame and Lava™ Frame Shade for the fabrication of abutments are completely met." This is a general statement of compliance, not a report on specific performance metrics or studies.

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