Ultra Dispersed Phase High Copper 099-55062A

GUDID D03309955062A1

Ultra Dispersed Phase High Copper Dental Amalgam Alloy 1 Spill Regular Set 500 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 IDD03309955062A1
NIH Device Record Key252f2529-9806-485b-bb84-8b46e7b92e95
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra Dispersed Phase High Copper
Version Model Number55062A
Catalog Number099-55062A
Company DUNS106792427
Company NameDMG AMERICA, LLC
Device Count500
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

Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 Milligram
Weight400 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
HIBCCD03309955062A0 [Unit of Use]
HIBCCD03309955062A1 [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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