Eugenol - 100 ml

Basic Information

• Brand Name: Eugenol - 100 ml
• Primary DI: 07640159162742
• Version / Model: 11422
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-15
• Public Version: 1
• Public Version Date: 2022-06-23
• Public Version Status: New
• Public Device Record Key: d5525325-0bef-46fc-9ae6-2564c690b275

Device Description

Eugenol - 100 ml Temporary filling and root canal sealing (mixed with Zinc Oxide powder)

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: Yes
• 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
EMB	Zinc Oxide Eugenol	Dental	872.3275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62200	Zinc oxide eugenol dental cement	A non-sterile, non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between eugenol and zinc oxide (ZnO). 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	07640159162742	GS1

Customer Contacts

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