IPS E.MAX CAD/IPS E.MAX ZIRCAD

Basic Information

• Brand Name: IPS E.MAX CAD/IPS E.MAX ZIRCAD
• Primary DI: 07630031703774
• Version / Model: Crowns
• Catalog Number: 010.5002
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-20
• Public Version: 3
• Public Version Date: 2023-10-25
• Public Version Status: Update
• Public Device Record Key: 31618222-0d29-4b0c-968a-8bdab32c9f89

Device Description

IPS e.max CAD restoration by Straumann CADCAM, Crown HT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	POWDER, PORCELAIN	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38594	Custom-made dental crown, ceramic	A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07630031703774	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]