DEVICE: Algin-X™ Ultra Alginate Alternative (D00261E8011)
Device Identifier (DI) Information
Algin-X™ Ultra Alginate Alternative
61E801
In Commercial Distribution
61E801
DENTSPLY INTERNATIONAL INC.
61E801
In Commercial Distribution
61E801
DENTSPLY INTERNATIONAL INC.
Algin-X™ Ultra Cartridge Bulk Refill
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 |
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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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. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4408c5ac-dd3a-44dd-9a73-269975870f88
April 28, 2022
1
April 20, 2022
April 28, 2022
1
April 20, 2022
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D00261E8010
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