Ena Bond ®

Basic Information

• Brand Name: Ena Bond ®
• Primary DI: EMICCOSM3M11
• Version / Model: COSM3M-1
• Catalog Number: COSM3M-1
• Company Name: MICERIUM SPA
• Labeler DUNS: 436661136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-08-06
• Public Version: 1
• Public Version Date: 2024-08-14
• Public Version Status: New
• Public Device Record Key: 3ce1723f-8b63-4153-b26e-64fbdb3b8b97

Device Description

ENA-BOND applicators, medium, blue 1pc

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJB	Handle, Instrument, Dental	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35697	Dental material application tool, single-use	A hand-held manual dental instrument intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient’s tooth/teeth; the restorative material is not included. It includes a handle with an application tip/brush which holds the material on its surface/bristles; it is not a syringe- or pistol-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EMICCOSM3M11	HIBCC

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 3 – 25 Degrees Celsius