Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D8387800M2
• Version / Model: 7800M
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2020-01-07
• Public Version: 1
• Public Version Date: 2020-01-15
• Public Version Status: New
• Public Device Record Key: a9ebcfaa-ed31-48cc-88cc-9ed44b02dd45

Device Description

Disposable fluoride trays

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
EHY	Tray, Impression, Preformed	Dental	872.6880	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16350	Dental impression tray, single-use	A horseshoe-shaped receptacle made of metal or plastic designed to carry dental impression material to the mouth, to confine the material in opposition to the surfaces to be recorded (e.g., teeth and gums), and to control the impression material while it sets to form an impression. The device is used mainly to facilitate the manufacturing of custom dental prostheses (e.g., dentures). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D8387800M8	HIBCC	CASE	10	In Commercial Distribution
Primary	D8387800M2	HIBCC
Unit of Use	D8387800M0	HIBCC