ZenithDental Royale Dispersed Phase High Copper 099-65008

GUDID D033099650081

ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam

• Primary Device ID: D033099650081
• NIH Device Record Key: 0f84dde1-70a5-48e3-8875-16c85f357212
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZenithDental Royale Dispersed Phase High Copper
• Version Model Number: 65008
• Catalog Number: 099-65008
• Company DUNS: 106792427
• Company Name: DMG AMERICA, LLC
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Device Dimensions

• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram
• Weight: 600 Milligram

Operating and Storage Conditions

• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D033099650080 [Unit of Use]
HIBCC	D033099650081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821222

FDA Product Code

• EJJ: Alloy, Amalgam

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-10-03
• Device Publish Date: 2016-09-23

On-Brand Devices [ZenithDental Royale Dispersed Phase High Copper]

• D033099651051: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 100 jar
• D033099651041: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 100 jar
• D033099651031: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 100 jar
• D033099650151: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 500 jar
• D033099650141: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 500 jar
• D033099650131: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 500 jar
• D033099650091: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 3 Spill Fast Set 50 jar
• D033099650081: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 2 Spill Fast Set 50 jar
• D033099650071: ZenithDental Royale Dispersed Phase High-Copper Dental Amalgam Alloy 1 Spill Fast Set 50 jar