JUVORA Dental Disc, Ceramill PEEK by JUVORA 010.4129

GUDID 07630031739667

CARES® 9-unit restoration, JUVORA(TM) PEEK

Institut Straumann AG

Dental bridge, polymer

• Primary Device ID: 07630031739667
• NIH Device Record Key: b6cfc07e-c04d-44d8-8364-0cd08e6ca281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: JUVORA Dental Disc, Ceramill PEEK by JUVORA
• Version Model Number: Bridges (tooth borne)
• Catalog Number: 010.4129
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com
• Phone: +1(801)448-8168
• Email: info.usa@straumann.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031739667 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160918

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

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

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

[07630031739667]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-25
• Device Publish Date: 2019-08-23

On-Brand Devices [JUVORA Dental Disc, Ceramill PEEK by JUVORA]

• 07630031739582: CARES® single-unit restoration, JUVORA(TM) PEEK
• 07630031739735: CARES® 16-unit restoration, JUVORA(TM) PEEK
• 07630031739728: CARES® 15-unit restoration, JUVORA(TM) PEEK
• 07630031739711: CARES® 14-unit restoration, JUVORA(TM) PEEK
• 07630031739704: CARES® 13-unit restoration, JUVORA(TM) PEEK
• 07630031739698: CARES® 12-unit restoration, JUVORA(TM) PEEK
• 07630031739681: CARES® 11-unit restoration, JUVORA(TM) PEEK
• 07630031739674: CARES® 10-unit restoration, JUVORA(TM) PEEK
• 07630031739667: CARES® 9-unit restoration, JUVORA(TM) PEEK
• 07630031739650: CARES® 8-unit restoration, JUVORA(TM) PEEK
• 07630031739643: CARES® 7-unit restoration, JUVORA(TM) PEEK
• 07630031739636: CARES® 6-unit restoration, JUVORA(TM) PEEK
• 07630031739629: CARES® 5-unit restoration, JUVORA(TM) PEEK
• 07630031739612: CARES® 4-unit restoration, JUVORA(TM) PEEK
• 07630031739605: CARES® 3-unit restoration, JUVORA(TM) PEEK
• 07630031739599: CARES® 2-unit restoration, JUVORA(TM) PEEK