Root Canal Instruments Kit

Basic Information

• Brand Name: Root Canal Instruments Kit
• Primary DI: 06970873260297
• Version / Model: DY21-1
• Company Name: DENJOY DENTAL CO.,LTD
• Labeler DUNS: 529329650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-19
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 89a46a59-6224-4156-b44d-870ae53a0cca

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NYC	Dental Prophylaxis Kit	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61457	Dental examination kit	A collection of various dental instruments and the necessary materials (e.g., aspiration cannula, forceps, mirror, probe, spatula, excavator) intended to be used to perform a dental examination. It does not contain any pharmaceuticals and is not intended for surgical procedures. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970873260297	GS1