X-TRA BASE

• K Number: K123773
• Device Name: X-TRA BASE
• Manufacturer: VOCO GMBH
• Date Cleared: 2012-12-21 ( 14 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

x-tra base:

• Base in class I and II cavities .
• Cavity lining under direct restorative materials in class I and II cavities ●
• Class III and V restorations .
• Conservative Class I restorations
• Small Class IV repairs .
• Tunnel Preparations .
• Filling of defects and undercuts in crown, inlay and onlay preparations .
• Blockouts .
• Repair of small enamel defects .
• Covering incisal edge stains .
• Pit and fissure sealant ●
• Cementing porcelain veneers, crowns, inlays and onlays ◆
• Intraoral porcelain repair .
• Amalgam margin repair .
• Improving margins of acrylic temporaries
• Provisional occlusal changes .
• Refacing acrylic temporaries ●
• Margin correction/adjustment of composite crowns for indirect laboratory use .

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental device called "X-Tra Base." It lists the indications for use of the device and confirms its substantial equivalence to a legally marketed predicate device, but it does not detail any specific performance metrics or the studies used to establish them.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.