neo.lign A tooth

Basic Information

• Brand Name: neo.lign A tooth
• Primary DI: EBRETOM48A30S0
• Version / Model: TOM48A30S
• Catalog Number: TOM48A30S
• Company Name: bredent GmbH & Co. KG
• Labeler DUNS: 341086190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-21
• Public Version: 3
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: e84a95d8-170a-4135-95d4-ac5fab990160

Device Description

neo.lign A tooth anterior M48 upper A30 6 parts (13,12,11,21,22,23) 1 Assortment

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ELM	Denture, plastic, teeth	Dental	872.3590	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38593	Custom-made dental crown, metal/ceramic	A device made of a combination of metal and tooth-coloured ceramic, 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
Package	EBRETOM48A30S9	HIBCC	dummy	1	Not in Commercial Distribution	2016-09-21
Primary	EBRETOM48A30S0	HIBCC

Customer Contacts

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