DEVICE: Aquasil Ultra DECA™ Smart Wetting® Impression Material (D0026787881)
Device Identifier (DI) Information
Aquasil Ultra DECA™ Smart Wetting® Impression Material
678788
In Commercial Distribution
678788
DENTSPLY INTERNATIONAL INC.
678788
In Commercial Distribution
678788
DENTSPLY INTERNATIONAL INC.
Aquasil Ultra Rigid Fast Set - Standard, 2x380ml
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 18 and 27 Degrees Celsius |
Special Storage Condition, Specify: Keep out of direct sunlight. |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 2 Cartridges, 20 Dynamic Mixing Tips, 1 Bayonet Locking Ring |
Total Volume: 380 Milliliter |
Device Record Status
a1aa665b-c88f-46fe-874b-34c33f6b99f4
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 |
---|---|---|---|---|---|
D00267878832 | 3 | D0026787881 | In Commercial Distribution | Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D0026787880
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