3M™ ESPE™

Basic Information

• Brand Name: 3M™ ESPE™
• Primary DI: 30605861011090
• Version / Model: 915100
• Catalog Number: 915100
• 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: 1
• Public Version Date: 2018-10-25
• Public Version Status: New
• Public Device Record Key: 8b833567-1235-4598-82c2-69c234bd2de8

Device Description

3M™ ESPE™ Strip Crown Forms - Pediatric Anterior Set, 915100

Device Characteristics

• Single Use: No
• 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	50605861011094	GS1	BOX	10	In Commercial Distribution
Primary	30605861011090	GS1
Unit of Use	00605861027212	GS1

Customer Contacts

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