THREAD FORMER M.1.8

Basic Information

• Brand Name: THREAD FORMER M.1.8
• Primary DI: D7700510753
• Version / Model: MF-380
• Catalog Number: MF-380
• Company Name: SWEDEN & MARTINA SPA
• Labeler DUNS: 433815198
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: ce433942-af4e-4baf-9a57-8e8f381edaa3

Device Description

THREAD FORMER M.1.8 INTERNAL IMPLANTS

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: Yes
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NDP	Accessories, Implant, Dental, Endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64528	Dental implant internal thread shaping tool	A cylindrical rod with a spiralled cutting distal end, similar to a drill bit or a screw, intended to be used to shape and rectify the internal thread of a dental implant that has been implanted into bone. It is made of metal and is designed to be attached to a manual screwdriver. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D7700510753	HIBCC

Customer Contacts

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