Premium Plus

Basic Information

• Brand Name: Premium Plus
• Primary DI: D838004YELLOW2
• Version / Model: 004B-YELLOW
• Company Name: Premium Plus International Limited
• Labeler DUNS: 668367758
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• 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: 1c81424e-d640-435a-8051-2857e90d4f69

Device Description

dappen dish

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
JDZ	Mixer, Cement, For Clinical Use	Orthopedic	888.4210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45120	Dappen dish, single-use	A small, shallow concave vessel made of a thermoplastic material used to mix dental materials chairside prior to application to the patient during dental procedures. The device is typically placed in a holder while the user dispenses the required amount of component materials into it and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. The device will then be placed in a hand-held holder for patient application. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	D838004YELLOW8	HIBCC	CASE	4	In Commercial Distribution
Package	D838004YELLOW6	HIBCC	BOX	5	In Commercial Distribution
Primary	D838004YELLOW2	HIBCC
Unit of Use	D838004YELLOW0	HIBCC