Ena Bond ® CFOTS

GUDID EMICCFOTS1

ENA-BOND SE LIGHT CURING BONDING 5 ml

MICERIUM SPA

Dentine bonding agent/set

• Primary Device ID: EMICCFOTS1
• NIH Device Record Key: 201a5a24-4d12-40f5-a39c-bbf2638e69bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena Bond ®
• Version Model Number: CFOTS
• Catalog Number: CFOTS
• 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

• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter
• Total Volume: 5 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICCFOTS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072978

FDA Product Code

• DYH: Adhesive, Bracket And Tooth Conditioner, 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: 2018-12-17
• Device Publish Date: 2018-11-16

On-Brand Devices [Ena Bond ®]

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• EMICCOSM300K1: ENA-BOND BI COMPONENT INTRO KIT Etch & Rinse Two-Component Bonding System 1 COSM300A Ena Bond L
• EMICCOSM300D1: ENA-BOND CATALYST 5ml
• EMICCOSM300D0: ENA-BOND CATALYST 5ml
• EMICCOSM300A20: ENA-BOND ONE COMPONENT BONDING 2ml
• EMICCOSM300A1: ENA-BOND ONE COMPONENT BONDING 5ml
• EMICCOSM3001: ENA-BOND ONE COMPONENT BONDING KIT Light curing one component Bonding System 1 COSM300A Ena Bond
• EMICCFOTX1: ENA-BOND SE KIT Bonding + Primer -1 CFOTS-2 (2 ml) -1 CFOTP-2 (2 ml)
• EMICCFOTS20: ENA-BOND SE LIGHT CURING BONDING 2 ml
• EMICCFOTS1: ENA-BOND SE LIGHT CURING BONDING 5 ml
• EMICCFOTS0: ENA-BOND SE LIGHT CURING BONDING 5 ml
• EMICCFOTP20: ENA-BOND SE Primer 2 ml
• EMICCFOTP1: ENA-BOND SE Primer 5 ml
• EMICCFOTP0: ENA-BOND SE Primer 5 ml
• EMICCFOTK1: ENA-BOND SE BONDING KIT Adesive + Primer + Etching Gel -1 CFOTS (5 ml) -1 CFOTP (5 ml) -1 COS101
• EMICCFOT1: ENA-BOND SE KIT Bonding + Primer -1 CFOTS (5 ml) -1 CFOTP (5 ml)
• EMICCOSM3M11: ENA-BOND applicators, medium, blue 1pc