3M™

Basic Information

• Brand Name: 3M™
• Primary DI: J001702011078390
• Version / Model: 78420
• Catalog Number: 78420
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 389ef3a1-d61d-4a7d-83b9-bef668b78d7c

Device Description

3M™ ESPE™ Visio™-Form Light-Cured Modelling Resin Refill, 78420

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EGD	WAX, DENTAL, INTRAORAL	Dental	872.6890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16189	Dental casting wax	A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the "lost-wax" casting technique. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	J001702011078390	HIBCC
Unit of Use	J001702011078394	HIBCC

Customer Contacts

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