ZenithDental Premium Dispersed Phase 099-61208

GUDID D033099612081

ZenithDental Premium Dispersed Phase Dental Amalgam Alloy 2 Spill Regular Set 100 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: D033099612081
• NIH Device Record Key: c0f0cec4-8752-43b6-8f16-6a6d6ab5d46c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZenithDental Premium Dispersed Phase
• Version Model Number: 61208
• Catalog Number: 099-61208
• Company DUNS: 106792427
• Company Name: DMG AMERICA, LLC
• Device Count: 100
• 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: 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
• 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
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D033099612080 [Unit of Use]
HIBCC	D033099612081 [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

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