DEVICE: Aquasil® Ultra+ Smart Wetting® Impression Material (D0026787111)

Device Identifier (DI) Information

Aquasil® Ultra+ Smart Wetting® Impression Material
678711
Not in Commercial Distribution
678711
DENTSPLY INTERNATIONAL INC.
D0026787111
HIBCC
May 03, 2024
1
083235549 *Terms of Use
Aquasil Ultra+ Tray Material Hand Mix Soft Putty Regular Set (Teal) with 50mL XLV Regular Set Wash Material
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ELW MATERIAL, IMPRESSION
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Do not use after expiration.
Storage Environment Temperature: between 5 and 27 Degrees Celsius
Special Storage Condition, Specify: Use the product at room temperature.
Special Storage Condition, Specify: Do not store used cartridges with new (unused) mix tips attached.
Special Storage Condition, Specify: Do not freeze.
Special Storage Condition, Specify: Protect from moisture.
Special Storage Condition, Specify: Store away from direct sunlight.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

31dd1ccb-8487-429d-a176-27c98f4c716f
May 03, 2024
3
April 20, 2022
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)532-2855
MilfordDE-Customer-Service@dentsplysirona.com
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