Ultra Dispersed Phase High Copper 099-55039

GUDID D033099550391

Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam
Primary Device IDD033099550391
NIH Device Record Key28bc9eea-66b0-4f17-bd90-96ba1e4b97e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra Dispersed Phase High Copper
Version Model Number55039
Catalog Number099-55039
Company DUNS106792427
Company NameDMG AMERICA, LLC
Device Count50
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
HIBCCD033099550390 [Unit of Use]
HIBCCD033099550391 [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 [Ultra Dispersed Phase High Copper]

D03309955064B1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Regular Set 500 jar
D033099550641Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D03309955063A1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Regular Set 500 jar
D033099550631Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D03309955062A1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Regular Set 500 jar
D033099550621Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D03309955044A1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Regular Set 50 jar
D033099550441Ultra Dispersed Phase High Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D03309955039A1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Regular Set 50 jar
D033099550391Ultra Dispersed Phase High Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D03309955038A1Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Regular Set 50 jar
D033099550381Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar

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