n!ce Glass Ceramic Blocks 010.5252

GUDID 07630031730947

n!ce® Veneer, XshadeX

Institut Straumann AG

Custom-made dental crown, ceramic

• Primary Device ID: 07630031730947
• NIH Device Record Key: 334eb026-bcd2-431f-b690-200d632c9142
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n!ce Glass Ceramic Blocks
• Version Model Number: Veneers
• Catalog Number: 010.5252
• 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
• 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	07630031730947 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160262

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

Moist Heat or Steam Sterilization

[07630031730947]

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: 2019-08-23

On-Brand Devices [n!ce Glass Ceramic Blocks]

• 07630031739766: n!ce® C, LT A2 & LT A3, A14L
• 07630031739759: n!ce® C, LT A3, A14L
• 07630031739742: n!ce® C, LT A2, A14L
• 07630031738707: n!ce® C, LT A3 & HT A3, C14
• 07630031738691: n!ce® C, LT A2 & HT A2, C14
• 07630031738684: n!ce® C, LT A2 & LT A3, C14
• 07630031738677: n!ce® C, HT A2 & HT A3, C14
• 07630031738660: n!ce® C, HT A3, C14
• 07630031738653: n!ce® C, HT A2, C14
• 07630031738646: n!ce® C, LT A3, C14
• 07630031738639: n!ce® C, LT A2, C14
• 07630031734891: n!ce®, HT Bleach, C14
• 07630031734853: n!ce®, LT Bleach, C14
• 07630031734679: n!ce® C, HT A3.5, C14
• 07630031734662: n!ce® C, HT B1, C14
• 07630031734655: n!ce® C, HT Bleach, C14
• 07630031734631: n!ce® C, LT A3.5, C14
• 07630031734624: n!ce® C, LT B1, C14
• 07630031734617: n!ce® C, LT Bleach, C14
• 07630031704528: n!ce® C, HT C2, C14
• 07630031704511: n!ce® C, HT B4, C14
• 07630031704504: n!ce® C, HT B2, C14
• 07630031704498: n!ce® C, HT A3, C14
• 07630031704481: n!ce® C, HT A2, C14
• 07630031704474: n!ce® C, HT A1, C14
• 07630031704467: n!ce® C, LT C2, C14
• 07630031704450: n!ce® C, LT B4, C14
• 07630031704443: n!ce® C, LT B2, C14
• 07630031704436: n!ce® C, LT A3, C14
• 07630031704429: n!ce® C, LT A2, C14
• 07630031704412: n!ce® C, LT A1, C14
• 07630031730961: n!ce® Inlay, XshadeX
• 07630031730954: n!ce® Onlay, XshadeX
• 07630031730947: n!ce® Veneer, XshadeX
• 07630031730930: n!ce® Partial Crown, XshadeX
• 07630031730923: n!ce® Crown, XshadeX