NA

Basic Information

• Brand Name: NA
• Primary DI: 07630031721150
• Version / Model: Non-invasive Instruments
• Catalog Number: 045.112V4
• Company Name: Institut Straumann AG
• Labeler DUNS: 483599259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2023-09-22
• Public Version: 1
• Public Version Date: 2023-10-02
• Public Version Status: New
• Public Device Record Key: f0018e3b-d5fe-4fb8-bc80-d5a159b959dc

Device Description

Cleaning brush for hollow instruments, nylon/stainless steel

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: 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
NDP	Accessories, implant, dental, endosseous	Dental	872.3980	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57955	Dental implant/teeth debridement brush, non-biodegradable	A rotary/oscillating dental instrument intended to be used by a dental hygienist and/or dentist for the non-surgical-invasive debridement of a patient's dental implants and/or teeth affected by peri-implant disease (peri-implant mucositis, peri-implantitis) or periodontitis. It is a brush-like device, typically consisting of titanium bristles at the distal end of a high-grade steel shaft, that is held in a dental handpiece which provides its rotation for the mechanical removal of biofilm from the surface of the implants and teeth. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	07630031757470	GS1
Primary	07630031721150	GS1

Customer Contacts

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