FDA.reportPublic FDA data

Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System

Primary DI
D0026786941
Brand
Aquasil® Ultra Smart Wetting® Impression Material in digit® Delivery System
Company
DENTSPLY INTERNATIONAL INC.
Model
678694
Catalog number
678694
Device description
Aquasil Ultra+ digit Power LV FS Small Cartridge Refill
Published
2022-04-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D0026786941PrimaryHIBCC0
D0026786940Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not freeze.
Special Storage Condition, Specify00Do not store used cartridges with new (unused) mix tips attached.
Special Storage Condition, Specify00Do not use after expiration.
Special Storage Condition, Specify00Protect from moisture.
Special Storage Condition, Specify00Store away from direct sunlight.
Special Storage Condition, Specify00Use the product at room temperature.
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
50
DM exempt
true
Lot or batch
true
Expiration date on label
true

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D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
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