Ena Matrix ENAM

GUDID EMICENAM1

Ena Matrix Standard "NiTi" Ring black for molars

MICERIUM SPA

Dental matrix band kit

• Primary Device ID: EMICENAM1
• NIH Device Record Key: ff63eb7b-e744-4a3a-a43b-aaabf1843e72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena Matrix
• Version Model Number: ENAM
• Catalog Number: ENAM
• Company DUNS: 436661136
• Company Name: MICERIUM SPA
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICENAM1 [Primary]

FDA Product Code

• EJB: Handle, Instrument, Dental

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

[EMICENAM1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-11
• Device Publish Date: 2023-05-03

On-Brand Devices [Ena Matrix]

• EMICENAM1: Ena Matrix Standard "NiTi" Ring black for molars
• EMICEMWW1: Ena Matrix Wooden wedges: 100 pcs Extra Small (orange); 100 pcs Small (white); 100 pcs Medium (y
• EMICEMAM01: Ena Matrix Standard "NiTi" Ring black for molars