Aquasil Ultra LV Fast Set Smart Wetting® Impression Material 678780

GUDID D00267878082

Aquasil Ultra LV Fast Set Cartridge Refill Package

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: D00267878082
• NIH Device Record Key: 18f5c74a-0a7e-4c6d-86da-1d0296ceaf22
• Commercial Distribution Discontinuation: 2021-07-06
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra LV Fast Set Smart Wetting® Impression Material
• Version Model Number: 678780
• Catalog Number: 678780
• 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	D0026787800 [Unit of Use]
HIBCC	D0026787801 [Primary]
HIBCC	D00267878082 [Package]; Contains: D0026787801; Package: Case [8 Units]; Discontinued: 2021-07-05; 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

Devices Manufactured by DENTSPLY INTERNATIONAL INC.

• D0026077000 - Calibra® Abutment: 2024-05-03 Calibra® Abutment Resin Cement Syringe Refill
• D0026077010 - Calibra® Abutment: 2024-05-03 Calibra® Abutment Resin Cement Sample
• D0026690011 - SmartCem®2 Self-Adhesive Cement: 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Introductory Kit
• D0026690031 - SmartCem®2 Self-Adhesive Cement: 2024-05-03 SmartCem®2 Self-Adhesive Cement Syringe Evaluator Kit
• D0026070711 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Light, 2 (1.8g) syringe Refill Package
• D0026070721 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Medium, 2 (1.8g) syringe Refill Package
• D0026070731 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Dark, 2 (1.8g) syringe Refill Package
• D0026070741 - Calibra® Esthetic Resin Cement: 2024-05-02 Calibra® Esthetic Resin Cement, Try-In Paste, Translucent, 2 (1.8g) syringe Refill Package