n!ce for Planmill 010.7147

GUDID 07630031735003

n!ce® for PlanMill®, LT B1, C14

Institut Straumann AG

Dental appliance fabrication material, ceramic

• Primary Device ID: 07630031735003
• NIH Device Record Key: a04df911-db29-4bee-a3cc-6ab814538a6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: n!ce for Planmill
• Version Model Number: Milling Materials
• Catalog Number: 010.7147
• 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: false
• 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(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	07630031735003 [Primary]
GS1	07630031748201 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173410

FDA Product Code

• EIH: POWDER, PORCELAIN

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: 2019-05-29
• Device Publish Date: 2019-05-21

On-Brand Devices [n!ce for Planmill]

• 07630031747402: n!ce® for PlanMill®, HT B4, C14
• 07630031735102: n!ce® for PlanMill®, HT A3.5, C14
• 07630031735096: n!ce® for PlanMill®, HT B1, C14
• 07630031735089: n!ce® for PlanMill®, HT Bleach, C14
• 07630031735065: n!ce® for PlanMill®, HT B2, C14
• 07630031735058: n!ce® for PlanMill®, HT A3, C14
• 07630031735041: n!ce® for PlanMill®, HT A2, C14
• 07630031735034: n!ce® for PlanMill®, HT A1, C14
• 07630031735010: n!ce® for PlanMill®, LT A3.5, C14
• 07630031735003: n!ce® for PlanMill®, LT B1, C14
• 07630031734990: n!ce® for PlanMill®, LT Bleach, C14
• 07630031734976: n!ce® for PlanMill®, LT B4, C14
• 07630031734969: n!ce® for PlanMill®, LT B2, C14
• 07630031734952: n!ce® for PlanMill®, LT A3, C14
• 07630031734945: n!ce® for PlanMill®, LT A2, C14
• 07630031734938: n!ce® for PlanMill®, LT A1, C14
• 07630031770929: n!ce® for PlanMill®, HT C2, C14
• 07630031775306: n!ce® for PlanMill®, HT D2, C14
• 07630031775290: n!ce® for PlanMill®, LT D2, C14
• 07630031775283: n!ce® for PlanMill®, LT C2, C14