CliXdish™

Basic Information

• Brand Name: CliXdish™
• Primary DI: D0026930061
• Version / Model: 693006
• Catalog Number: 693006
• Company Name: DENTSPLY INTERNATIONAL INC.
• Labeler DUNS: 083235549
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2022-08-16
• Public Version: 1
• Public Version Date: 2022-08-24
• Public Version Status: New
• Public Device Record Key: 7c7ec0cd-f2a0-4efc-8d9a-44df59c15785

Device Description

CliXdish™ Mixing Well Refill

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLE	AGENT, TOOTH BONDING, RESIN	Dental	872.3200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45119	Dappen dish, reusable	A small, shallow, hand-held concave vessel made of glass or metal used to mix dental materials chairside prior to application to the patient during dental procedures. The user dispenses the required amount of component materials into the device and mixes them by hand (e.g., with a spatula) until the consistency of the mixture is appropriate. It is most often used for prophy and fluoride treatments, for mixing composite materials, acrylics, cements, and amalgams. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	D0026930060	HIBCC
Primary	D0026930061	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5 CliXdishes

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from direct sunlight.