combo.lign B2

Basic Information

• Brand Name: combo.lign B2
• Primary DI: EBRECO2X4B200
• Version / Model: CO2X4B20
• Catalog Number: CO2X4B20
• Company Name: bredent GmbH & Co. KG
• Labeler DUNS: 341086190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 3e869bb0-ad90-4200-84aa-d2ea0247fe5b

Device Description

combo.lign B2 Dual-hardening, luting composite 8 g

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EBF	MATERIAL, TOOTH SHADE, RESIN	Dental	872.3690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38645	Dental veneer, professional	A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EBRECO2X4B209	HIBCC	dummy	1	Not in Commercial Distribution	2016-09-20
Primary	EBRECO2X4B200	HIBCC

Customer Contacts

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