FDA.reportPublic FDA data

Algin-X™ Ultra Alginate Alternative

Primary DI
D00261E8011
Brand
Algin-X™ Ultra Alginate Alternative
Company
DENTSPLY INTERNATIONAL INC.
Model
61E801
Catalog number
61E801
Device description
Algin-X™ Ultra Cartridge Bulk Refill
Published
2022-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELWMATERIAL, IMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELWMaterial, ImpressionDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D00261E8011PrimaryHIBCC0
D00261E8010Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Silicone dental impression materialAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Allow sufficient warm-up time if product was stored in a refrigerator.
Special Storage Condition, Specify00Do not freeze. Protect from moisture.
Special Storage Condition, Specify00Do not use after expiration date.
Special Storage Condition, Specify00Refrigerated storage is acceptable when not in use.
Special Storage Condition, Specify00Use product at room temperature.
Storage Environment Temperature2 Degrees Celsius24 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)532-2855MilfordDE-Customer-Service@dentsplysirona.com

Regulatory Flags#

DUNS number
083235549
Device count
24
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D0026243451Enhance® mini Finishing System6243456243452022-04-11
D0026243551Enhance® mini Finishing System6243556243552022-04-11
D0026243651Enhance® mini Finishing System6243656243652022-04-11
D0026243751Enhance® mini Finishing System6243756243752022-10-13
D0026243851Enhance® mini Finishing System6243856243852022-04-11
D002624550001Polytrays62455000624550002022-07-07
D002624550011Polytrays62455001624550012022-07-07
D002624550021Polytrays62455002624550022022-07-07
D002624551001Polytrays62455100624551002022-07-07
D002624551011Polytrays62455101624551012022-07-07
D002624551021Polytrays62455102624551022022-07-07
D002624551031Polytrays62455103624551032022-07-07
D002624551051Polytrays62455105624551052022-07-07
D0026076071Calibra® Bio Bioceramic Luting Cement6076076076072022-04-20
D0026590301Palodent® Sectional Matrix System6590306590302019-04-02
D0026590701Palodent® Sectional Matrix System6590706590702019-04-02
D0026631001AutoMate®6631006631002019-04-02
D0013010121Ceramco® 3Powder Opaque i2/i43010122016-09-21
D0013010211Ceramco® 3Powder Opaque D23010212016-09-21
D0013010311Ceramco® 3Powder Opaque Modifier Yellow3010312016-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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18016200010496IQ TROPICAL - alginato cromatico tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
08800024205816Delikit 7.0 Light Body FastSherpakoreaELW2023-01-16
08800024205908Delikit 7.0 Extra Light Body FastSherpakoreaELW2023-01-16
08800024204420Delikit 7.0 Light Body RegularSherpakoreaELW2023-01-12
08800024204451Delikit 3.0 Light BodySherpakoreaELW2023-01-12
08800024204468Delikit 3.0 Light Body FastSherpakoreaELW2023-01-12
08800024204475Delikit 3.0 Extra Light Body FastSherpakoreaELW2023-01-12
08800024205397Delikit Putty Eco Fast SetSherpakoreaELW2023-01-12
08800024203805Delikit 3.0 Light BodySherpakoreaELW2022-09-15
08800024203997Delikit 3.0 Light Body FastSherpakoreaELW2022-09-15
07640181478934AFFINISColtène/Whaledent AGELW2022-03-27
07640181478958AFFINISColtène/Whaledent AGELW2022-03-27
07640181478972AFFINISColtène/Whaledent AGELW2022-03-27
07640181479030AFFINISColtène/Whaledent AGELW2022-03-27
07640181479054AFFINISColtène/Whaledent AGELW2022-03-27
07640181479061AFFINISColtène/Whaledent AGELW2022-03-27
07640181479115AFFINISColtène/Whaledent AGELW2022-03-27
07640181479146AFFINISColtène/Whaledent AGELW2022-03-27
07640181479153AFFINISColtène/Whaledent AGELW2022-03-27
07640181479160AFFINISColtène/Whaledent AGELW2022-03-27
07640181479177AFFINISColtène/Whaledent AGELW2022-03-27
07640181479214AFFINISColtène/Whaledent AGELW2022-03-27
07640181479238AFFINISColtène/Whaledent AGELW2022-03-27
07640181479245AFFINISColtène/Whaledent AGELW2022-03-27
07640181479290AFFINISColtène/Whaledent AGELW2022-03-27
07640181479306AFFINISColtène/Whaledent AGELW2022-03-27
07640181479313AFFINISColtène/Whaledent AGELW2022-03-27