Ena HFO ® EHFUD1

GUDID EMICEHFUD10

Ena HFO Flow UD1 2 g Light Curing Composite

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICEHFUD10
• NIH Device Record Key: 2845abf5-bae3-4402-af10-61b0b6bbcfe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena HFO ®
• Version Model Number: EHFUD1
• Catalog Number: EHFUD1
• 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: false
• 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	EMICEHFUD10 [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