Aquasil Ultra Xtra DECA™ Smart Wetting® Impression Material 678715

GUDID D00267871532

Impression Material, Xtra, Tray, with B4™ Pre-Imp Surface Optimizer, 2 (380ml) DECA™ Cartridges Standard

DENTSPLY INTERNATIONAL INC.

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• Primary Device ID: D00267871532
• NIH Device Record Key: a9ee5aea-6cf7-402a-930d-f040a0252ead
• Commercial Distribution Discontinuation: 2020-11-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aquasil Ultra Xtra DECA™ Smart Wetting® Impression Material
• Version Model Number: 678715
• Catalog Number: 678715
• Company DUNS: 083235549
• Company Name: DENTSPLY INTERNATIONAL INC.
• Device Count: 2
• 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

Device Dimensions

• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0
• Total Volume: 380 Milliliter
• Device Size Text, specify: 0

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.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D0026787150 [Unit of Use]
HIBCC	D0026787151 [Primary]
HIBCC	D00267871532 [Package]; Contains: D0026787151; Package: Box [3 Units]; Discontinued: 2020-10-31; 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: 2024-01-25
• Device Publish Date: 2016-09-21

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