Vita CAD-Temp For Inlab 010.4031

GUDID 07630031744289

CARES® single unit restoration, VITA® CAD-Temp® , monoColor xSHADEx

Institut Straumann AG

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• Primary Device ID: 07630031744289
• NIH Device Record Key: 2b2cedcf-52df-4d32-ae9f-7208741a25df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vita CAD-Temp For Inlab
• Version Model Number: Crowns
• Catalog Number: 010.4031
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031744289 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070991

FDA Product Code

• EBG: CROWN AND BRIDGE, TEMPORARY, RESIN

Sterilization

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

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

[07630031744289]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-03-10
• Device Publish Date: 2019-07-23

On-Brand Devices [Vita CAD-Temp For Inlab]

• 07630031744449: CARES® single unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744289: CARES® single unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744593: CARES® 16-unit restoration, VITA® CAD-Temp®, multiColor xSHADEx
• 07630031744586: CARES® 15-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744579: CARES® 14-unit restoration, VITA® CAD-Temp®, monoColor xSHADEx
• 07630031744562: CARES® 13-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744555: CARES® 12-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744548: CARES® 11-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744531: CARES® 10-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744524: CARES® 9-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744517: CARES® 8-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744500: CARES® 7-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744494: CARES® 6-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744487: CARES® 5-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744470: CARES® 4-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744463: CARES® 3-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744456: CARES® 2-unit restoration, VITA® CAD-Temp® , multiColor xSHADEx
• 07630031744432: CARES® 16-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744425: CARES® 15-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744418: CARES® 14-unit restoration, VITA® CAD-Temp®, monoColor xSHADEx
• 07630031744401: CARES® 13-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744395: CARES® 12-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744388: CARES® 11-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744371: CARES® 10-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744364: CARES® 9-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744357: CARES® 8-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744340: CARES® 7-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744333: CARES® 6-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744326: CARES® 5-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744319: CARES® 4-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744302: CARES® 3-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx
• 07630031744296: CARES® 2-unit restoration, VITA® CAD-Temp® , monoColor xSHADEx