FDA.reportPublic FDA data

AxioSil Monophase

Primary DI
D161260070
Brand
AxioSil Monophase
Company
Axiodent Inc.
Model
26007 2 x 50ml Regular Set
Published
2024-10-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
D161260070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Composite dental impression materialA thermoplastic material designed 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. It is composed of a mixture of natural resins, fillers, and lubricants. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119330625
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D161280140AxioIRM 15g powder 10ml liquid280142024-09-29
D161280150AxioIRM 75g powder 40ml liquid280152024-09-29
D161280160AxioIRM XS 38g powder 14ml liquid280162024-09-29
D161280170AxioZi-Temp 15g powder 10ml liquid280172024-09-29
D161270050AxioPrint C&B Interim500g 270052025-01-19
D161270060AxioPrint C&B Interim1000g 270062025-01-19
D161270070AxioPrint C&B Permanent500g 270072025-01-19
D161270080AxioPrint C&B Permanent1000g 270082025-01-19
D161270130AxioPrint C&B Ceramic500g 270132025-01-19
D161270140AxioPrint C&B Ceramic1000g 270142025-01-19
D161270150AxioPrint C&B Interim250g 270152025-01-19
D161270160AxioPrint C&B Permanent250g 270162025-01-19
D161270170AxioPrint C&B Ceramic250g 270172025-01-19
D161230560AxioComp NT23056 20 x 0.25g unit dose compules Shade A32024-11-12
D161230570AxioComp NT23057 20 x 0.25g unit dose compules Shade A3.52024-11-12
D161230580AxioComp NT23058 20 x 0.25g unit dose compules Shade A42024-11-12
D161230590AxioComp NT23059 20 x 0.25g unit dose compules Shade B12024-11-12
D161230600AxioComp NT23060 20 x 0.25g unit dose compules Shade B22024-11-12
D161230610AxioComp NT23061 20 x 0.25g unit dose compules Shade B32024-11-12
D161230620AxioComp NT23062 20 x 0.25g unit dose compules Shade C12024-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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18016200010748IQ - alginato chrom viola/lilla/verde tipo 1 (24x450g)LASCOD SPAELW2026-05-27
18016200011318Mono7LASCOD SPAELW2026-05-27
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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
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07640181479313AFFINISColtène/Whaledent AGELW2022-03-27