Ditron Dental

Basic Information

• Brand Name: Ditron Dental
• Primary DI: 07290109286259
• Version / Model: TD500L16C
• Catalog Number: TD500L16C
• 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: 2
• Public Version Date: 2023-07-21
• Public Version Status: Update
• Public Device Record Key: d0ae4276-1633-4130-bfe2-0bc25b37ad3c

Device Description

Coated Twist Drill ø5.0 L16mm Integral Stopper

Device Characteristics

• Single Use: No
• 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: 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
DZA	Drill, Dental, Intraoral	Dental	872.4130	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45714	Fixture/appliance dental drill bit, reusable	A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290109286259	GS1

Customer Contacts

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