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 Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic Dental appliance fabrication material, thermoplastic 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