Durelon™

Basic Information

• Brand Name: Durelon™
• Primary DI: J001702011360100
• Version / Model: 38236
• Catalog Number: 38236
• Company Name: 3M Deutschland GmbH
• Labeler DUNS: 315731711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• 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: 2176b65d-1e3b-47e2-a667-a2a73c411a57

Device Description

3M™ ESPE™ Durelon™ Carboxylate Luting Cement Triple Pack Powder, 38236

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
EMA	CEMENT, DENTAL	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16705	Zinc polycarboxylate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. 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	J001702011360100	HIBCC
Unit of Use	J001702011360104	HIBCC

Customer Contacts

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