CERAMILL PEEK by JUVORA™

GUDID 05055948225386

CERAMILL PEEK by JUVORA™ 760371, Natural 101 x 13/US – 1 unit

JUVORA LIMITED

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 05055948225386
• NIH Device Record Key: 8a80d50b-fb31-4b6f-b5d8-9017b0a856ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERAMILL PEEK by JUVORA™
• Version Model Number: 760371
• 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
• Phone: +4401253898000
• Email: info@juvoradental.com
• Phone: +4401253898000
• Email: info@juvoradental.com
• Phone: +4401253898000
• Email: info@juvoradental.com
• Phone: +4401253898000
• Email: info@juvoradental.com
• Phone: +4401253898000
• Email: info@juvoradental.com

Device Dimensions

• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter
• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter
• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter
• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter
• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter
• Height: 13 Millimeter
• Outer Diameter: 101 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055948225386 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132725

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-24

On-Brand Devices [CERAMILL PEEK by JUVORA™ ]

• 05055948228639: CERAMILL PEEK by JUVORA™ 760401, Natural 98 x 12/US – 1 unit
• 05055948228622: CERAMILL PEEK by JUVORA™ 760402, Natural 98x20/US – 1 unit
• 05055948225393: CERAMILL PEEK by JUVORA™ 760373, Natural 101 x 20/US – 1 unit
• 05055948225386: CERAMILL PEEK by JUVORA™ 760371, Natural 101 x 13/US – 1 unit