Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D838T221PK2
• Version / Model: T221PK
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-01-02
• Public Version: 1
• Public Version Date: 2020-01-10
• Public Version Status: New
• Public Device Record Key: 59c85b77-40a6-4fc1-9bf7-1a0191e2f7ef

Device Description

PROPHY CUPS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
EHK	Cup, Prophylaxis	Dental	872.6290	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46938	Dental polishing cup, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D838T221PK8	HIBCC	CASE	10	In Commercial Distribution
Package	D838T221PK6	HIBCC	BOX	10	In Commercial Distribution
Primary	D838T221PK2	HIBCC
Unit of Use	D838T221PK0	HIBCC