Nobilium

Basic Information

• Brand Name: Nobilium
• Primary DI: M482689LT4LR0
• Version / Model: 689LT4LR
• Company Name: CMP INDUSTRIES LLC
• Labeler DUNS: 002064319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-16
• Public Version: 1
• Public Version Date: 2018-05-17
• Public Version Status: New
• Public Device Record Key: 6af85753-a0f4-405e-a4b3-6031f61fdabf

Device Description

EDENT LOW TEMP TRAY 4L

Device Characteristics

• Single Use: Yes
• 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: 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
NFS	Device, Jaw Tracking, For Monitoring Jaw Positions	Dental	872.2060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
18083	Bite registration rim	A schematic model of the dental arch attached to a temporary or permanent base for recording jaw relationships. Bite rims can be individually made or adjusted to one patient from preformed devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M482689LT4LR0	HIBCC