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 ID: D033099550531
• NIH Device Record Key: 3dfa460f-2d5d-45c3-a308-aadbc19514d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Dispersed Phase
• Version Model Number: 55053
• Catalog Number: 099-55053
• 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
• Phone: 201-894-5505
• Email: eanagnostos@dmg-america.com

Device Dimensions

• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 Milligram
• Weight: 400 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
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D033099550530 [Unit of Use]
HIBCC	D033099550531 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K820617

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: 2022-09-19
• Device Publish Date: 2016-09-23

On-Brand Devices [Ultra Dispersed Phase ]

• D033099550731: Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 500 kjar
• D033099550721: Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 500 jar
• D033099550711: Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 500 jar
• D033099550701: Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 500 jar
• D033099550691: Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 500 jar
• D033099550681: Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 500 jar
• D033099550551: Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Fast Set 50 jar
• D033099550541: Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Fast Set 50 jar
• D033099550531: Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Fast Set 50 jar
• D033099550521: Ultra Dispersed Phase Dental Amalgam Alloy 3 Spill Regular Set 50 jar
• D033099550511: Ultra Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 50 jar
• D033099550501: Ultra Dispersed Phase Dental Amalgam Alloy 1 Spill Regular Set 50 jar