N!CE LT Glass Ceramic Blocks, N!CE HT Glass Ceramic Blocks 010.7115

GUDID 07630031770905

n!ce® C, HT D2, C14

Institut Straumann AG

Dental appliance fabrication material, ceramic

• Primary Device ID: 07630031770905
• NIH Device Record Key: 27a3a917-e9fb-4ce4-b018-02547de3bca7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N!CE LT Glass Ceramic Blocks, N!CE HT Glass Ceramic Blocks
• Version Model Number: Milling Materials
• Catalog Number: 010.7115
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 5
• 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: 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: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)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
• 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	07630031734686 [Primary]
GS1	07630031770905 [Unit of Use]

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

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

[07630031770905]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-22
• Device Publish Date: 2022-04-14

On-Brand Devices [N!CE LT Glass Ceramic Blocks, N!CE HT Glass Ceramic Blocks]

• 07630031770905: n!ce® C, HT D2, C14
• 07630031770899: n!ce® C, LT D2, C14