JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White

• K Number: K181331
• Device Name: JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White
• Manufacturer: Juvora, Ltd.
• Date Cleared: 2018-12-21 ( 214 days)
• Product Code: EBI , EBF , EBG
• Regulation Number: 872.3760
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A

Intended Use

The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of:

i) full and partial removable dentures and implant overdentures.

ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

Device Description

The JUVORA™ Oyster White Dental Disc is a thermoplastic dental disc.

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a dental disc, outlining its regulatory status and intended use. It does not include details on performance studies, sample sizes, ground truth establishment, or expert qualifications.

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.