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 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: 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

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