Ena HRI Flow EHR2F

GUDID EMICEHR2F0

ENA HRI FLOW KIT 9x2g

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICEHR2F0
• NIH Device Record Key: 9e3162f8-df50-4af5-89dd-540d990666dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena HRI Flow
• Version Model Number: EHR2F
• Catalog Number: EHR2F
• Company DUNS: 436661136
• Company Name: MICERIUM SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	EMICEHR2F0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062906

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-21
• Device Publish Date: 2025-04-11

On-Brand Devices [Ena HRI Flow]

• EMICEHR5F1: ENA HRI FLOW KIT 5x2g
• EMICEHR5F0: ENA HRI FLOW KIT 5x2g
• EMICEHR2F1: ENA HRI FLOW KIT 9x2g
• EMICEHR2F0: ENA HRI FLOW KIT 9x2g
• EMICEHR1F1: INTRO KIT ENA HRI FLOW 7x2g
• EMICEHR1F0: INTRO KIT ENA HRI FLOW 7x2g