Aquasil Ultra Smart Wetting® Impression Material Cartridge System 678350

GUDID D00267835082

Aquasil Rigid Regular Set Cartridge Refill Package - Light Green

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 IDD00267835082
NIH Device Record Keyd771d9a5-c051-47cb-b74f-71d20070e1a8
Commercial Distribution Discontinuation2023-07-22
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAquasil Ultra Smart Wetting® Impression Material Cartridge System
Version Model Number678350
Catalog Number678350
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
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter
Device Size Text, specify0
Total Volume50 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0026783500 [Unit of Use]
HIBCCD0026783501 [Primary]
HIBCCD00267835082 [Package]
Contains: D0026783501
Package: Box [8 Units]
Discontinued: 2023-07-21
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

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

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D002678885122Aquasil Ultra XLV Super Fast Set 2-Pack Cartridge Refill Package - Orange
D00267842582Aquasil LV Regular Set Cartridge Refill Package - Teal
D00267825082Aquasil Monophase Regular Set Cartridge Refill Package - Purple
D00267841582Aquasil LV Fast Set Cartridge Refill Package -Teal
D00267835082Aquasil Rigid Regular Set Cartridge Refill Package - Light Green

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