Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System 678130

GUDID D00267813082

Aquasil Ultra LV Regular Set (Teal) Cartridge Refill Package with B4™ Optimizer

DENTSPLY INTERNATIONAL INC.

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: D00267813082
• NIH Device Record Key: 6e1048f5-1d51-458c-bd5b-e09ecb1be6b8
• Commercial Distribution Discontinuation: 2022-12-15
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra Smart Wetting® Impression Material with B4™ Cartridge System
• Version Model Number: 678130
• Catalog Number: 678130
• 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: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 Milliliter
• Device Size Text, specify: 0
• Total Volume: 6 Milliliter
• Total Volume: 50 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	D0026781300 [Unit of Use]
HIBCC	D0026781301 [Primary]
HIBCC	D00267813082 [Package]; Contains: D0026781301; Package: Case [8 Units]; Discontinued: 2022-12-15; 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