JUVORA™ Dental Disc

GUDID 05055948200444

JUVORA™ Dental Disc, 540024, US-DD-98-30-02

JUVORA LIMITED

Dental appliance fabrication material, thermoplastic

• Primary Device ID: 05055948200444
• NIH Device Record Key: 60072600-4a61-4a85-9b99-c098a1cf595c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUVORA™ Dental Disc
• Version Model Number: 540024
• 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

• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter
• Outer Diameter: 98 Millimeter
• Height: 30 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055948200444 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-16
• Device Publish Date: 2018-06-14

On-Brand Devices [JUVORA™ Dental Disc ]

• 05055948229698: JUVORA™ Natural Dental Disc - 95mm x 16mm 1 unit
• 05055948229568: JUVORA™ Dental Disc, 540050, US-DD-95-20-03
• 05055948229551: JUVORA™ Dental Disc, 540049, US-DD-95-16-03
• 05055948200444: JUVORA™ Dental Disc, 540024, US-DD-98-30-02
• 05055948200437: JUVORA™ Dental Disc, 540023, US-DD-98-30-01
• 05055948200420: JUVORA™ Dental Disc, 540022, US-DD-98-25-02
• 05055948200413: JUVORA™ Dental Disc, 540021, US-DD-98-25-01
• 05055948200406: JUVORA™ Dental Disc, 540020, US-DD-98-22-02
• 05055948200390: JUVORA™ Dental Disc, 540019, US-DD-98-22-01
• 05055948200383: JUVORA™ Dental Disc, 540018, US-DD-98-20-02
• 05055948200376: JUVORA™ Dental Disc, 540017, US-DD-98-20-01
• 05055948200369: JUVORA™ Dental Disc, 540016, US-DD-98-18-02
• 05055948200352: JUVORA™ Dental Disc, 540015, US-DD-98-18-01
• 05055948200345: JUVORA™ Dental Disc, 540014, US-DD-98-16-02
• 05055948200338: JUVORA™ Dental Disc, 540013, US-DD-98-16-01