Ena Post

Basic Information

• Brand Name: Ena Post
• Primary DI: EMICCS0504R1
• Version / Model: CS050-4R
• Catalog Number: CS050-4R
• Company Name: MICERIUM SPA
• Labeler DUNS: 436661136
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2023-05-03
• Public Version: 1
• Public Version Date: 2023-05-11
• Public Version Status: New
• Public Device Record Key: f60e2d5e-b50c-4fe3-b1f3-46c6b64f7ca9

Device Description

Enamel Plus Shiny Ricambi - Diamond strips

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHM	Strip, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63358	Dental abrasive strip, reusable	A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying (e.g., polishing, finishing, contouring, reducing) the surface of a tooth or restoration during a dental procedure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	EMICCS0504R0	HIBCC
Primary	EMICCS0504R1	HIBCC

Device Sizes

Type	Value	Unit	Text
Length	120	Millimeter
Height	2.0	Millimeter