Ena Matrix

Basic Information

• Brand Name: Ena Matrix
• Primary DI: EMICENAM1
• Version / Model: ENAM
• Catalog Number: EMAM
• Company Name: MICERIUM SPA
• Labeler DUNS: 436661136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-03
• Public Version: 2
• Public Version Date: 2023-09-04
• Public Version Status: Update
• Public Device Record Key: ff63eb7b-e744-4a3a-a43b-aaabf1843e72

Device Description

Ena Matrix Standard "NiTi" Ring black for molars

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62764	Dental matrix band kit	A collection of non-sterile devices intended for the temporary introduction of a dental matrix band to form a mould around a tooth prior to tooth restoration using a direct restorative material (not included). Often referred to as a dental matrix system, it includes a matrix band(s), matrix band tensioner, dental wedge, and appropriate forceps. This device is reusable after appropriate cleaning/sterilization of the reusable instruments, and when the consumable products have been replenished.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EMICENAM1	HIBCC