SmartBrush2

Basic Information

• Brand Name: SmartBrush2
• Primary DI: 08800209394847
• Version / Model: OOPISB25L
• Company Name: Osstem Implant Co., Ltd.
• Labeler DUNS: 689051793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-08
• Public Version: 1
• Public Version Date: 2023-08-16
• Public Version Status: New
• Public Device Record Key: 84e8de80-5a15-4750-ae76-f0cacff98318

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: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
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
Primary	08800209394847	GS1