Ultra Dispersed Phase 099-55053

GUDID D033099550531

Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam
Primary Device IDD033099550531
NIH Device Record Key3dfa460f-2d5d-45c3-a308-aadbc19514d3
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltra Dispersed Phase
Version Model Number55053
Catalog Number099-55053
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
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
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
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD033099550530 [Unit of Use]
HIBCCD033099550531 [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 Date2022-09-19
Device Publish Date2016-09-23

On-Brand Devices [Ultra Dispersed Phase ]

D033099550731Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 500 kjar
D033099550721Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099550711Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099550701Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 500 jar
D033099550691Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 500 jar
D033099550681Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 500 jar
D033099550551Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099550541Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099550531Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 50 jar
D033099550521Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 50 jar
D033099550511Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 50 jar
D033099550501Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 50 jar

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