ZenithDental Premium Dispersed Phase 099-61013

GUDID D033099610131

ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam
Primary Device IDD033099610131
NIH Device Record Keyd4c3212d-8b55-4a73-9a3d-b55f0196d458
Commercial Distribution StatusIn Commercial Distribution
Brand NameZenithDental Premium Dispersed Phase
Version Model Number61013
Catalog Number099-61013
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

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
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
Storage Environment TemperatureBetween -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD033099610130 [Unit of Use]
HIBCCD033099610131 [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 [ZenithDental Premium Dispersed Phase]

D033099612111ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 100 jar
D033099612101ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 100 jar
D033099612091ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 100 jar
D033099612081ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 100 jar
D033099612071ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 100 jar
D033099612061ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 100 jar
D033099610291ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D033099610281ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 500 jar
D033099610251ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099610241ZenithDental Premium Dispersed PhaseDental Amalgam Alloy 2 Spill Regular Set 500 jar
D033099610211ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099610201ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 500 jar
D033099610171ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099610161ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 50 jar
D033099610131ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099610121ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 50 jar
D033099610091ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 50 jar
D033099610081ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 50 jar
D033099610051ZenithDental Premium Dispersed Phase Dental Alloy Tablets Fast Set 5Toz
D033099610041ZenithDental Premium Dispersed Phase Dental Alloy Tablets Regular Set 5Toz
D033099610011ZenithDental Premium Dispersed Phase Dental Alloy Powder Fast Set 5Toz
D033099600001ZenithDental Premium Dispersed Phase Dental Alloy Powder Regular Set 5Toz

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