Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material 678970

GUDID D0026789700

Aquasil Ultra XLV Fast Set 50 ML Single

DENTSPLY INTERNATIONAL INC.

Silicone dental impression material
Primary Device IDD0026789700
NIH Device Record Key9c69e4c1-c4c3-4d65-8673-a89e38c882c9
Commercial Distribution Discontinuation2024-06-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAquasil Ultra XLV Fast Set Smart Wetting® Impression Material
Version Model Number678970
Catalog Number678970
Company DUNS083235549
Company NameDENTSPLY INTERNATIONAL INC.
Device Count1
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. 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
HIBCCD0026789700 [Primary]

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 Date2024-06-03
Device Publish Date2016-09-21

On-Brand Devices [Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material]

D00267888282Aquasil Ultra XLV Fast Set Smart Wetting® Impression Material Cartridge Refill Package
D0026789700Aquasil Ultra XLV Fast Set 50 ML Single
D002678870122Aquasil Ultra XLV Fast Set 2-Pack Cartridge Refill Case (12)

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