3M™ ESPE™

Basic Information

• Brand Name: 3M™ ESPE™
• Primary DI: 30605861032910
• Version / Model: 3402
• Catalog Number: 3402
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 120
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2018-11-08
• Public Version Status: Update
• Public Device Record Key: 9eba6da2-f6f1-423e-8084-cfff4e1d7581

Device Description

3M™ ESPE™ Bendable Applicator Brushes, 3402

Device Characteristics

• Single Use: Yes
• 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: No
• 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
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
Package	50605861032914	GS1	BOX	10	In Commercial Distribution
Primary	30605861032910	GS1
Unit of Use	00605861032919	GS1

Customer Contacts

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