DEVICE: Algin-X™ Ultra Alginate Alternative (D00261E8011)

Device Identifier (DI) Information

Algin-X™ Ultra Alginate Alternative
61E801
In Commercial Distribution
61E801
DENTSPLY INTERNATIONAL INC.
D00261E8011
HIBCC

24
083235549 *Terms of Use
Algin-X™ Ultra Cartridge Bulk Refill
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
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: Use product at room temperature.
Special Storage Condition, Specify: Do not freeze. Protect from moisture.
Special Storage Condition, Specify: Allow sufficient warm-up time if product was stored in a refrigerator.
Special Storage Condition, Specify: Refrigerated storage is acceptable when not in use.
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Do not use after expiration date.
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Clinically Relevant Size

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

4408c5ac-dd3a-44dd-9a73-269975870f88
April 28, 2022
1
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: D00261E8010 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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