DEVICE: Aquasil Ultra Heavy Fast Set Smart Wetting® Impression Material (D0026788761)
Device Identifier (DI) Information
Aquasil Ultra Heavy Fast Set Smart Wetting® Impression Material
678876
In Commercial Distribution
678876
DENTSPLY INTERNATIONAL INC.
678876
In Commercial Distribution
678876
DENTSPLY INTERNATIONAL INC.
Aquasil Ultra Heavy FS 2-Pack Cartridge Refill Case (12)
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
35866 | Silicone dental impression material |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ELW | MATERIAL, IMPRESSION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 10 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep away from direct sunlight. Keep dry. |
Clinically Relevant Size
[?]Size Type Text |
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Total Volume: 50 Milliliter |
Device Size Text, specify: 12 boxes containing 2 Heavy FS Cartridges (50ml) and 6 Mixing Tips in each |
Device Record Status
563a0a96-b332-4aa6-94c5-1ba41384acc8
March 29, 2018
2
September 21, 2016
March 29, 2018
2
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D002678876122 | 12 | D0026788761 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D0026788760
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
MilfordDE-Customer-Service@dentsplysirona.com