ZenithDental Royale Dispersed Phase High Copper

Basic Information

• Brand Name: ZenithDental Royale Dispersed Phase High Copper
• Primary DI: D033099651031
• Version / Model: 65103
• Catalog Number: 099-65103
• Company Name: DMG AMERICA, LLC
• Labeler DUNS: 106792427
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-10-03
• Public Version Status: Update
• Public Device Record Key: 50274047-e76d-43f2-b6ab-12050140558b

Device Description

ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 100 jar

Device Characteristics

• Single Use: Yes
• 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: 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
EJJ	Alloy, Amalgam	Dental	872.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16367	Dental amalgam	A dental restorative material used primarily to fill tooth cavities, prepared by mixing liquid mercury (Hg) with an alloy of fine particles, composed mainly of silver (Ag), tin (Sn) and copper (Cu). The amalgam may be in either powder or tablet form, or in capsules, with portions of alloy and mercury predosed by the manufacturer. 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	D033099651031	HIBCC
Unit of Use	D033099651030	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K821222	000

Device Sizes

Type	Value	Unit	Text
Weight	400	Milligram

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -4 – 25 Degrees Celsius