Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System 678140

GUDID D00267814082

Aquasil Ultra XLV Regular Set, with B4™ Pre-Impression Surface Optimizer Cartridge Refill Package (Orange)

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D00267814082
• NIH Device Record Key: c0c3b50a-a8d4-4843-ba64-424b8d312b81
• Commercial Distribution Discontinuation: 2023-01-23
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System
• Version Model Number: 678140
• Catalog Number: 678140
• 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: true
• 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
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter
• Device Size Text, specify: 0
• Total Volume: 50 Milliliter
• Total Volume: 6 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026781400 [Unit of Use]
HIBCC	D0026781401 [Primary]
HIBCC	D00267814082 [Package]; Contains: D0026781401; Package: Case [8 Units]; Discontinued: 2023-01-20; 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: 2023-12-20
• Device Publish Date: 2016-09-21

On-Brand Devices [Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System]

• D00267816082: Aquasil Ultra XLV Fast Set, with B4™ Pre-Impression Surface Optimizer Cartridge Refill Package
• D00267815082: Aquasil Ultra LV Fast Set (Teal) Cartridge Refill Package with B4™ Optimizer
• D00267814082: Aquasil Ultra XLV Regular Set, with B4™ Pre-Impression Surface Optimizer Cartridge Refill Pack
• D00267813082: Aquasil Ultra LV Regular Set (Teal) Cartridge Refill Package with B4™ Optimizer