Dispersed Phase Alloy CAP Fast Set 3 SPILL 9526854

GUDID 20889813001589

Dispersed Phase Alloy CAP Fast Set 3 SPILL

DARBY DENTAL SUPPLY, 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 Dental amalgam

• Primary Device ID: 20889813001589
• NIH Device Record Key: e6d31193-c712-44ea-8b44-6d62db1f36ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dispersed Phase Alloy CAP Fast Set 3 SPILL
• Version Model Number: 9526854
• Catalog Number: 9526854
• Company DUNS: 825137818
• Company Name: DARBY DENTAL SUPPLY, LLC
• Device Count: 500
• 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

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

Operating and Storage Conditions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889813001585 [Unit of Use]
GS1	20889813001589 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821222

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 [Dispersed Phase Alloy CAP Fast Set 3 SPILL]

• 20889813001589: Dispersed Phase Alloy CAP Fast Set 3 SPILL
• 10889813001582: Dispersed Phase Alloy CAP Fast Set 3 SPILL