FDA.reportPublic FDA data

Aquasil® Ultra Smart Wedding Impression Material

Primary DI
D002678769KR1
Brand
Aquasil® Ultra Smart Wedding Impression Material
Company
DENTSPLY INTERNATIONAL INC.
Model
678769KR
Catalog number
678769KR
Device description
Aquasil® Ultra XLV Regular Set Cartridge Refill (Asia Only)
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D002678769KR1PrimaryHIBCC0
D002678769KR0Unit 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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) mixing tips attached.
Special Storage Condition, Specify00Do not use after expiration date.
Special Storage Condition, Specify00Protect from moisture.
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
4
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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