Colour Liquid D4 (50 ml)

Basic Information

• Brand Name: Colour Liquid D4 (50 ml)
• Primary DI: D800FMAA1602
• Version / Model: FMAA1602
• Company Name: ZIRKONZAHN SRL
• Labeler DUNS: 564251911
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-04
• Public Version: 3
• Public Version Date: 2019-01-23
• Public Version Status: Update
• Public Device Record Key: d0338569-f240-4d6d-8e8c-e3005e17edc9

Device Description

Content: 50 ml Colour Liquid for Zirconia Translucent and Zirconia Abutments for dipping technique. Our recommendation: Using metal-free tweezers.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EIH	POWDER, PORCELAIN	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17844	Dental articulation paste/solution	A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D800FMAA1602	HIBCC

Customer Contacts

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