Endobrushes

Basic Information

• Brand Name: Endobrushes
• Primary DI: EDMG2123861
• Version / Model: 212386
• Catalog Number: 212386
• Company Name: DMG Chemisch-Pharmazeutische Fabrik GmbH
• Labeler DUNS: 320744915
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 1
• Public Version Date: 2022-09-09
• Public Version Status: New
• Public Device Record Key: 4c17165c-2258-4f4d-93bd-c7bd5061f8eb

Device Description

Endobrushes Black. Suitable for LuxaBond Total-Etch. Content: 25 Brushes

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KXR	Applicator, Resin	Dental	872.3140	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
Unit of Use	EDMG2123860	HIBCC
Primary	EDMG2123861	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]