Formula-T Spherical Alloy Fast Set 2 SPILL 9513958

GUDID 20889813001510

Formula-T Spherical Alloy Fast Set 2 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 Dental amalgam

• Primary Device ID: 20889813001510
• NIH Device Record Key: ed158cd5-a145-44d9-9826-e5ec3bade57d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Formula-T Spherical Alloy Fast Set 2 SPILL
• Version Model Number: 9513958
• Catalog Number: 9513958
• 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
• Phone: +1(516)688-6800
• Email: Robyn.livingston@darby.com

Device Dimensions

• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0
• Weight: 600 Milligram
• Device Size Text, specify: 0

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
• 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	00889813001516 [Unit of Use]
GS1	20889813001510 [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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-06-24

Devices Manufactured by DARBY DENTAL SUPPLY, LLC

• 00889813061657 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT RES P10 25K
• 00889813061664 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT SC P10 30K
• 00889813061671 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT RES XTH 25K
• 00889813061688 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT RES XTH 30K
• 00889813061695 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT SIL P10 25K
• 00889813061701 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT SIL P10 30K DARBY
• 00889813061718 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC INSERT SIL XTH 30K
• 00889813061725 - Darby Dental Supply, LLC: 2024-04-12 ULTRASONIC SCALER