FDA.report

Axio-3D Burnout 1000g

Primary DI
D161270120
Brand
Axio-3D Burnout 1000g
Company
Axiodent Inc.
Model
27012
Published
2024-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D161270120PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods

Method

Regulatory Flags

DUNS number
119330625
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
D161230630AxioComp NT23063 20 x 0.25g unit dose compules Shade C22024-11-12
D161230640AxioComp NT23064 20 x 0.25g unit dose compules Shade C32024-11-12
D161230650AxioComp NT23065 20 x 0.25g unit dose compules Shade D12024-11-12
D161230660AxioComp NT23066 20 x 0.25g unit dose compules Shade D22024-11-12
D161230670AxioComp NT23067 20 x 0.25g unit dose compules Shade D32024-11-12
D161230680AxioComp NT23068 20 x 0.25g unit dose compules Shade Incisal2024-11-12
D161230690AxioComp NT23069 20 x 0.25g unit dose compules Shade Opaque2024-11-12
D161230700AxioComp NT23070 20 x 0.25g unit dose compules Shade OA12024-11-12
D161230710AxioComp NT23071 20 x 0.25g unit dose compules Shade OA22024-11-12
D161230720AxioComp NT23072 20 x 0.25g unit dose compules Shade OA32024-11-12
D161230730AxioComp NT23073 20 x 0.25g unit dose compules Shade Extra Bl2024-11-12
D161230740AxioComp NT23074 20 x 0.25g unit dose compules Shade Bleach2024-11-12
D161230750AxioComp NT23075 20 x 0.25g unit dose compules Shade Gingival2024-11-12

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