Ultra High Copper Spherical 099-55045

GUDID D033099550451

Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar

DMG AMERICA, LLC

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam

• Primary Device ID: D033099550451
• NIH Device Record Key: efbf42c0-b71c-48cb-b8e8-31eceb807208
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra High Copper Spherical
• Version Model Number: 55045
• Catalog Number: 099-55045
• 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	D033099550450 [Unit of Use]
HIBCC	D033099550451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K951865

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 High Copper Spherical]

• D033099550671: Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 500 jar
• D033099550661: Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 500 jar
• D033099550651: Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 500 jar
• D033099550471: Ultra High Copper Spherical Dental Amalgam Alloy 3 Spill Fast Set 50 jar
• D033099550461: Ultra High Copper Spherical Dental Amalgam Alloy 2 Spill Fast Set 50 jar
• D033099550451: Ultra High Copper Spherical Dental Amalgam Alloy 1 Spill Fast Set 50 jar