ZenithDental Type-T High Copper Spherical 099-61040

GUDID D033099610401

ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam
Primary Device IDD033099610401
NIH Device Record Key8a33bbd4-5a31-4f5d-ab5c-fb27d736aeee
Commercial Distribution StatusIn Commercial Distribution
Brand NameZenithDental Type-T High Copper Spherical
Version Model Number61040
Catalog Number099-61040
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
HIBCCD033099610400 [Unit of Use]
HIBCCD033099610401 [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 Type-T High Copper Spherical]

D033099610491ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 100 jar
D033099610481ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 100 jar
D033099610471ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 100 jar
D033099610411ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar
D033099610401ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar
D033099610391ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar
D033099610371ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 500 jar
D033099610361ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 500 jar
D033099610351ZenithDental Type-T High-Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 500 jar
D033099610061ZenithDental Type-T High Copper Spherical Dental Alloy Tablets Micro Fast Set 5Toz
D033099610021ZenithDental Type-T High Copper Spherical Dental Alloy Powder Micro Fast Set 5Toz

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