Vertex-Dental BV

Basic Information

• Brand Name: Vertex-Dental BV
• Primary DI: 08719425508115
• Version / Model: NOWHOCCL01000
• Company Name: Vertex-Dental B.V.
• Labeler DUNS: 406389056
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-14
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: e87b8395-c94c-4a2a-91f3-3522fae84941

Device Description

NextDent Ortho Clear / Clear

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: No
• 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
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	No	Active
43025	Dental occlusal splint, custom-made	A rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used 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). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08719425508115	GS1