GUTTA PERCHA POINT 2% - N°25

Basic Information

• Brand Name: GUTTA PERCHA POINT 2% - N°25
• Primary DI: 08809264293041
• Version / Model: 24004
• Company Name: Produits dentaires S.A.
• Labeler DUNS: 480420090
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-22
• Public Version: 1
• Public Version Date: 2022-06-30
• Public Version Status: New
• Public Device Record Key: 4a52dc28-1d0d-4b24-b610-327016f035d2

Device Description

Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated. Box of 120 pieces - Length 28mm - Color Code: Red

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EKM	Gutta-Percha	Dental	872.3850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31872	Natural gutta-percha	A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. 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	08809264293041	GS1

Customer Contacts

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