Ceramill PEEK by JUVORA™ Oyster White

GUDID 05055948229308

CERAMILL PEEK by JUVORA™ 760403, Oyster White 98x12 – 1 unit

JUVORA LIMITED

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 05055948229308
• NIH Device Record Key: 87055f6b-78c9-450b-86e8-6cf2648c5942
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ceramill PEEK by JUVORA™ Oyster White
• Version Model Number: 760403
• Company DUNS: 218501322
• Company Name: JUVORA LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401253898000
• Email: info@juvoradental.com

Device Dimensions

• Height: 12 Millimeter
• Outer Diameter: 98 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055948229308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181331

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-21
• Device Publish Date: 2019-01-21

On-Brand Devices [Ceramill PEEK by JUVORA™ Oyster White]

• 05055948229315: CERAMILL PEEK by JUVORA™ 760404, Oyster White 98x20 – 1 unit
• 05055948229308: CERAMILL PEEK by JUVORA™ 760403, Oyster White 98x12 – 1 unit
• 05055948229292: CERAMILL PEEK by JUVORA™ 760394, Oyster White 71x20 – 1 unit
• 05055948229254: CERAMILL PEEK by JUVORA™ 760393, Oyster White 71x13 – 1 unit