EssenSeal

Basic Information

• Brand Name: EssenSeal
• Primary DI: 07640159162704
• Version / Model: 10246
• Catalog Number: EssenSeal
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-13
• Public Version: 1
• Public Version Date: 2022-06-21
• Public Version Status: New
• Public Device Record Key: 5812961b-6109-41ef-930b-41156c6fdaf8

Device Description

EssenSeal is a permanent endodontic sealer used with obturation points (made of gutta-percha) to seal tightly root canals. This device, a zinc oxide – eugenol based dental cement, consists of two parts, the powder and the liquid, which are mixed before use to form a paste of creamy consistency.

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	07640159162704	GS1