Ditron Dental

Basic Information

• Brand Name: Ditron Dental
• Primary DI: 07290109285870
• Version / Model: MSBOX-002C
• Catalog Number: MSBOX-002C
• Company Name: DITRON DENTAL LTD
• Labeler DUNS: 531878633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 3
• Public Version Date: 2023-07-24
• Public Version Status: Update
• Public Device Record Key: a679c09e-71ee-4ba2-985c-a44c7ecf8fa0

Device Description

Mini Surgical Kit - Coated Drills

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OFY	Dental Implant Surgical Tray	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45147	Dental/maxillofacial surgical procedure kit, non-medicated, reusable	A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109285870	GS1

Customer Contacts

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