UltraPro Tx

Basic Information

• Brand Name: UltraPro Tx
• Primary DI: 00883205026293
• Version / Model: 8356
• Catalog Number: 8356
• Company Name: ULTRADENT PRODUCTS, INC.
• Labeler DUNS: 013369913
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-07-31
• Public Version: 1
• Public Version Date: 2018-08-31
• Public Version Status: New
• Public Device Record Key: 9913313b-120e-4e2f-925e-c67f51537ac2

Device Description

Ultrapro Tx Disposable Prophy Pointed Brush Tip 100 pack

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: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EHK	CUP, PROPHYLAXIS	Dental	872.6290	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16184	Dental polishing cup, reusable	A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00883205026293	GS1

Customer Contacts

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