GUTTA PERCHA POINTS

Basic Information

• Brand Name: GUTTA PERCHA POINTS
• Primary DI: 08806383509268
• Version / Model: DIA-PROISO-.04 20
• Catalog Number: 158-604
• Company Name: DiaDent Group International
• Labeler DUNS: 687789453
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-06
• Public Version: 1
• Public Version Date: 2020-04-14
• Public Version Status: New
• Public Device Record Key: 55f7c605-58cd-4657-96d6-b0fb6633b198

Device Description

Gutta Percha Points is used to root canal filing material.

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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	08806383509268	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 27 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from flammable and combustible materials and heat
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry and away from Sunlight