Aquasil Ultra Smart Wetting® Impression Material Cartridge System 678415

GUDID D00267841582

Aquasil LV Fast Set Cartridge Refill Package -Teal

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D00267841582
• NIH Device Record Key: 5c31a7e9-dceb-40d5-a061-e03d08dc348a
• Commercial Distribution Discontinuation: 2023-07-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra Smart Wetting® Impression Material Cartridge System
• Version Model Number: 678415
• Catalog Number: 678415
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 4
• 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: false
• 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
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026784150 [Unit of Use]
HIBCC	D0026784151 [Primary]
HIBCC	D00267841582 [Package]; Contains: D0026784151; Package: Box [8 Units]; Discontinued: 2023-07-21; Not in Commercial Distribution

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2024-01-30
• Device Publish Date: 2016-09-21

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