P.004 NC GOLD ABUTMENT FOR CROWNS 022.2410

GUDID 07630031708014

NC Gold Abutment, for crown, H 3.7mm, Ceramicor®/POM

Institut Straumann AG

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 07630031708014
• NIH Device Record Key: 99a5de32-d31e-4350-9d37-55c611925b0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: P.004 NC GOLD ABUTMENT FOR CROWNS
• Version Model Number: Final Abutments
• Catalog Number: 022.2410
• Company DUNS: 483599259
• Company Name: Institut Straumann AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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(800)448-8168
• Email: info.usa@straumann.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630031708014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072497

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[07630031708014]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-24

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• 07630031742322 - Straumann TLX Implant System: 2025-06-16 TLX SP Implant, Ø 4.0mm NT, SLA® 18mm, Roxolid®