EVOLUX CAD/CAM PMMA BLOCKS

• K Number: K182065
• Device Name: EVOLUX CAD/CAM PMMA BLOCKS
• Manufacturer: Blue Dent Dental
• Date Cleared: 2018-12-13 ( 134 days)
• Product Code: EBG
• Regulation Number: 872.3770
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.

Indications:

• Temporary anterior and posterior crowns
• Temporary anterior and posterior bridges with up to two adjacent pontics
• Implant supported temporary restorations
• Maximum recommended usage period: 12 months
• Removable structures for dentures (dental bases)
• Removable structures for therapeutic restorations (bite splints or occlusal splints)

Device Description

Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.

AI/ML Overview

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance for the "Evolux Cad/cam Pmma Blocks". The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

Regulation Number and Section

§ 872.3770 Temporary crown and bridge resin.

(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.