Contours™ Course Anatomy Trimers Starter Kit

Basic Information

• Brand Name: Contours™ Course Anatomy Trimers Starter Kit
• Primary DI: 00359883003111
• Version / Model: 078918
• Catalog Number: 078918
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-12
• Public Version: 1
• Public Version Date: 2025-03-20
• Public Version Status: New
• Public Device Record Key: bcca1a55-d349-4fc7-ab9d-9b294a186f5d

Device Description

Dental mandrel

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
EJR	AGENT, POLISHING, ABRASIVE, ORAL CAVITY	Dental	872.6030	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31833	Dental abrasive point, reusable	A rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00359883003111	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature