Unison® Spherical Alloy 657-2611

GUDID D00265726112

Unison® Spherical Alloy Self-Activating Capsules, 1 Spill, 500 (400mg) Brown/White caps

DENTSPLY INTERNATIONAL INC.

Dental amalgam alloy

• Primary Device ID: D00265726112
• NIH Device Record Key: 6164b83d-9d54-4f34-8c68-8cd8b9034392
• Commercial Distribution Discontinuation: 2021-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Unison® Spherical Alloy
• Version Model Number: 657-2611
• Catalog Number: 657-2611
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• 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: 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

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.
• Special Storage Condition, Specify: Between 0 and 0 *Store in a well-ventilated place and do not exceed 25 segrees Celsius.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D00265726110 [Unit of Use]
HIBCC	D00265726111 [Primary]
HIBCC	D00265726112 [Package]; Contains: D00265726111; Package: Case [10 Units]; Discontinued: 2021-07-31; 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: 2023-12-19
• Device Publish Date: 2016-09-21

On-Brand Devices [Unison® Spherical Alloy]

• D00265726112: Unison® Spherical Alloy Self-Activating Capsules, 1 Spill, 500 (400mg) Brown/White caps
• D00265726132: Unison® Spherical Alloy Self-Activating Capsules, 3 Spill, 500 (800mg) Beige/White caps
• D00265726122: Unison® Spherical Alloy Self-Activating Capsules, 2 Spill, 500 (600mg) Orange/White caps