ZenithDental Royale Dispersed Phase High Copper 099-65104

GUDID D033099651041

ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 100 jar

DMG AMERICA, LLC

Dental amalgam
Primary Device IDD033099651041
NIH Device Record Key1118d6dc-6258-4281-be8b-7254ff33c9ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameZenithDental Royale Dispersed Phase High Copper
Version Model Number65104
Catalog Number099-65104
Company DUNS106792427
Company NameDMG AMERICA, LLC
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com
Phone201-894-5505
Emaileanagnostos@dmg-america.com

Device Dimensions

Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram
Weight600 Milligram

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD033099651040 [Unit of Use]
HIBCCD033099651041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, Amalgam

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2022-10-03
Device Publish Date2016-09-23

On-Brand Devices [ZenithDental Royale Dispersed Phase High Copper]

D033099651051ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 100 jar
D033099651041ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 100 jar
D033099651031ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 100 jar
D033099650151ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D033099650141ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099650131ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099650091ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099650081ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099650071ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar

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