Gutapercha ApicalShaper Z35

Basic Information

• Brand Name: Gutapercha ApicalShaper Z35
• Primary DI: 00810092939009
• Version / Model: GP-435
• Company Name: NUSMILE, LTD.
• Labeler DUNS: 185497372
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 2
• Public Version Date: 2023-08-22
• Public Version Status: Update
• Public Device Record Key: cb6ef12c-eb89-4215-aa77-7472df4babca

Device Description

60 units

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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	00810092939009	GS1

Customer Contacts

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