Aquasil Ultra Xtra Smart Wetting® Impression Material Cartridge System 678705

GUDID D00267870582

Aquasil Ultra Xtra with B4™ Pre-Impression Surface Optimizer Material Wash Material 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 IDD00267870582
NIH Device Record Key3c840ad5-8525-44e6-ac6a-da0cf1ab08d9
Commercial Distribution Discontinuation2020-11-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAquasil Ultra Xtra Smart Wetting® Impression Material Cartridge System
Version Model Number678705
Catalog Number678705
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count4
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com
Phone+1(800)532-2855
EmailMilfordDE-Customer-Service@dentsplysirona.com

Device Dimensions

Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Total Volume6 Milliliter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight. Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026787050 [Unit of Use]
HIBCCD0026787051 [Primary]
HIBCCD00267870582 [Package]
Contains: D0026787051
Package: Box [8 Units]
Discontinued: 2020-10-31
Not in Commercial Distribution

FDA Product Code

ELWMATERIAL, IMPRESSION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2024-01-30
Device Publish Date2016-09-21

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