D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL 9526968

GUDID 10889813001612

D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL

DARBY DENTAL SUPPLY, LLC

Dental amalgam

• Primary Device ID: 10889813001612
• NIH Device Record Key: 8c09fe9f-b449-4fd4-b9b7-c159e6464ec9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL
• Version Model Number: 9526968
• Catalog Number: 9526968
• Company DUNS: 825137818
• Company Name: DARBY DENTAL SUPPLY, LLC
• Device Count: 50
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com

Device Dimensions

• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram
• Device Size Text, specify: 0
• Weight: 800 Milligram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store in cool well-ventilated place
• Storage Environment Temperature: Between -4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889813001615 [Unit of Use]
GS1	10889813001612 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-24

On-Brand Devices [D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL]

• 20889813001619: D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL
• 10889813001612: D-Phase II Amalgam Alloy CAP Regular Set 3 SPILL