JOTA

Basic Information

• Brand Name: JOTA
• Primary DI: EJOT803204030524060
• Version / Model: 9813M.RA.060
• Company Name: Jota AG
• Labeler DUNS: 480670983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-21
• Public Version: 1
• Public Version Date: 2023-09-29
• Public Version Status: New
• Public Device Record Key: db414d3e-89ad-4e61-860e-8db4d4c9ae73

Device Description

Polishers

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: Yes
• 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: Yes
• Has Expiration Date: Yes
• 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
EJQ	Wheel, Polishing Agent	Dental	872.6010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46940	Dental polishing brush	A rotational device, typically composed of a metal shaft with bristles containing silicium carbide material, that is used for the quick grinding and polishing of dental composite materials and hard dental tissues to produce a high shine. It is held in a dental handpiece, which rotates the brush at high speeds [e.g., 5000 revolutions per minute (rpm)]. It is suitable for interproximal areas and occlusal surfaces. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	EJOT803204030524060	HIBCC