Ena HFO ® EHFUD5

GUDID EMICEHFUD51

Ena HFO Flow UD5 2g Light Curing Composite

MICERIUM SPA

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: EMICEHFUD51
• NIH Device Record Key: 274a8a09-ca2c-4261-aaa0-1e0459636ece
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena HFO ®
• Version Model Number: EHFUD5
• Catalog Number: EHFUD5
• 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: false
• 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 Dimensions

• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram
• Weight: 2 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICEHFUD51 [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: 2021-12-09
• Device Publish Date: 2021-12-01

On-Brand Devices [Ena HFO ®]

• EMICEHTUD31: Ena HFO Dentin UD3 12 tips x 0.3 g each Light Curing Composite
• EMICEHFUD60: Ena HFO Flow UD6 2 g Light Curing Composite
• EMICEHFUD51: Ena HFO Flow UD5 2g Light Curing Composite
• EMICEHFUD50: Ena HFO Flow UD5 2 g Light Curing Composite
• EMICEHFUD41: Ena HFO Flow UD4 2g Light Curing Composite
• EMICEHFUD40: Ena HFO Flow UD4 2 g Light Curing Composite
• EMICEHFUD351: Ena HFO Flow UD3.5 2g Light Curing Composite
• EMICEHFUD350: Ena HFO Flow UD3.5 2 g Light Curing Composite
• EMICEHFUD31: Ena HFO Flow UD3 2g Light Curing Composite
• EMICEHFUD30: Ena HFO Flow UD3 2 g Light Curing Composite
• EMICEHFUD21: Ena HFO Flow UD2 2g Light Curing Composite
• EMICEHFUD20: Ena HFO Flow UD2 2 g Light Curing Composite
• EMICEHFUD11: Ena HFO Flow UD1 2g Light Curing Composite
• EMICEHFUD10: Ena HFO Flow UD1 2 g Light Curing Composite
• EMICEHFB41: Ena HFO Flow B3 2g Light Curing Composite
• EMICEHFB40: Ena HFO Flow B4 2 g Light Curing Composite
• EMICEHFB31: Ena HFO Flow B3 2g Light Curing Composite
• EMICEHFB30: Ena HFO Flow B3 2 g Light Curing Composite
• EMICEHFGC1: Ena HFO ® ENA Glass Connector 1g +3 tips
• EMICEHFGC0: Ena HFO ® ENA Glass Connector 1g +3 tips