Megalloy®EZ Spherical Amalgam 603014

GUDID D0026030142

Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 1 Spill Case (Red)

DENTSPLY INTERNATIONAL INC.

Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy Dental amalgam alloy

• Primary Device ID: D0026030142
• NIH Device Record Key: 0295d66e-c678-4792-97dd-6bf51d063e91
• Commercial Distribution Discontinuation: 2021-08-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Megalloy®EZ Spherical Amalgam
• Version Model Number: 603014
• Catalog Number: 603014
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 250
• DM Exempt: true
• 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: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com
• Phone: +1(800)532-2855
• Email: MilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0
• Weight: 400 Milligram
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store out of Direct Sunlight and do not exceed a temperature of 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026030140 [Unit of Use]
HIBCC	D0026030141 [Primary]
HIBCC	D0026030142 [Package]; Contains: D0026030141; Package: Case [4 Units]; Discontinued: 2021-07-30; Not in Commercial Distribution

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: 2023-12-20
• Device Publish Date: 2016-09-21

On-Brand Devices [Megalloy®EZ Spherical Amalgam]

• D0026030042: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red)
• D0026030162: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Case (Lime Green)
• D0026030152: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple)
• D0026030062: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 3 Spill (Lime Green)
• D0026030052: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 2 Spill (Purple)
• D0026030142: Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 1 Spill Case (Red)