Vertex-Dental BV

Basic Information

• Brand Name: Vertex-Dental BV
• Primary DI: 08720604633894
• Version / Model: NDORBL01000_01
• Company Name: Vertex-Dental B.V.
• Labeler DUNS: 406389056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-19
• Public Version: 2
• Public Version Date: 2024-10-21
• Public Version Status: Update
• Public Device Record Key: 9940c59c-2916-4c77-a403-e552a49e6406

Device Description

For manufacturing 3d printed dental splints

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
DYT	MAINTAINER, SPACE PREFORMED, ORTHODONTIC	Dental	872.5525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43025	Removable dental occlusal splint, custom-made	A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08720604633894	GS1