JUVORA™ Oyster White Dental Disc

GUDID 05055948229612

JUVORA™ Oyster White Dental Disc - 98mm x 16mm 1 unit

JUVORA LIMITED

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 05055948229612
• NIH Device Record Key: d094d6fd-a420-4bc0-9057-dd00656b4919
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUVORA™ Oyster White Dental Disc
• Version Model Number: 540103
• 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

• Outer Diameter: 98 Millimeter
• Height: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055948229612 [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 [JUVORA™ Oyster White Dental Disc ]

• 05055948229681: JUVORA™ Oyster White Dental Disc - 95mm x 20mm 1 unit
• 05055948229674: JUVORA™ Oyster White Dental Disc - 95mm x 16mm 1 unit
• 05055948229667: JUVORA™ Oyster White Dental Disc - 98mm x 30mm 1 unit
• 05055948229650: JUVORA™ Oyster White Dental Disc - 98mm x 25mm 1 unit
• 05055948229643: JUVORA™ Oyster White Dental Disc - 98mm x 22mm 1 unit
• 05055948229636: JUVORA™ Oyster White Dental Disc - 98mm x 20mm 1 unit
• 05055948229629: JUVORA™ Oyster White Dental Disc - 98mm x 18mm 1 unit
• 05055948229612: JUVORA™ Oyster White Dental Disc - 98mm x 16mm 1 unit