3M™ ESPE™

Basic Information

• Brand Name: 3M™ ESPE™
• Primary DI: 30605861026698
• Version / Model: 914004
• Catalog Number: 914004
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: c02b4fca-2f16-4073-8c9d-e4539597b4b4

Device Description

3M™ ESPE™ Pedodontic Anterior Strip Crown Form, Upper Left Central, Size 4, 914004

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: 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
KCQ	TUBE IMPRESSION AND MATRIX	Dental	872.6570	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38786	Dental matrix band, single-use	A band or strip of strong material (typically a transparent plastic) or a short tube that is used to form a mould around a tooth for the insertion of restorative materials. The device is typically held snugly around the tooth by a matrix retainer. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50605861026692	GS1	BOX	5	In Commercial Distribution
Primary	30605861026698	GS1
Unit of Use	00605861024013	GS1

Customer Contacts

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