Vertex-Dental BV

Basic Information

• Brand Name: Vertex-Dental BV
• Primary DI: 08719425508948
• Version / Model: NDCMN101000_1
• Company Name: Vertex-Dental B.V.
• Labeler DUNS: 406389056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-03
• Public Version: 1
• Public Version Date: 2023-08-11
• Public Version Status: New
• Public Device Record Key: d578662f-5100-41d1-afdd-ce39bd98c195

Device Description

Micro Filled Hybrid 3D Print resin for the manufacturing of long-term temporaries

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
ELJ	TEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT	Dental	872.3900	1
ELK	TEETH, ARTIFICIAL, BACKING AND FACING	Dental	872.3910	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	No	Active
37542	Dental bridge, polymer	A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.	No	Active
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
Primary	08719425508948	GS1