visio.lign shield HV

Basic Information

• Brand Name: visio.lign shield HV
• Primary DI: EBREVLSHIELDHV50
• Version / Model: VLSHIELDHV5
• Catalog Number: VLSHIELDHV5
• Company Name: bredent GmbH & Co. KG
• Labeler DUNS: 341086190
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-10
• Public Version: 1
• Public Version Date: 2025-03-18
• Public Version Status: New
• Public Device Record Key: 8d71db6d-8f36-418a-b218-3baf1864244a

Device Description

visio.lign shield HV 5 ml

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: MR Safe
• 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
EBD	Coating, filling material, resin	Dental	872.3310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38781	Dental prosthesis veneer resin	A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EBREVLSHIELDHV59	HIBCC	dummy	1	Not in Commercial Distribution	2025-03-10
Primary	EBREVLSHIELDHV50	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K240735	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: keep out of sunlight