3M™ ESPE™

Basic Information

• Brand Name: 3M™ ESPE™
• Primary DI: 30605861025899
• Version / Model: 61
• Catalog Number: 61
• 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: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: 25569959-20fd-43be-b636-e3c14f0099f0

Device Description

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Long Lower Anterior, Size 61, 61

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
ELZ	CROWN, PREFORMED	Dental	872.3330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34976	Preformed dental crown, temporary	A prefabricated tooth crown, usually made of stainless steel, aluminium (Al) or resin, that is designed to be fitted over a damaged or prepared tooth of a baby/child (primary tooth) or post-pubescent/adult patient (permanent tooth) to serve as a temporary device, typically until the natural tooth falls out or until the fitting of a permanent crown (not included). This device is commonly used during prosthodontic treatment or other restorative work required as a result of traumatic injury.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50605861025893	GS1	BOX	5	In Commercial Distribution
Primary	30605861025899	GS1
Unit of Use	00605861023757	GS1

Customer Contacts

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