FDA.reportPublic FDA data

Axcent Acrylics

Primary DI
D79330180010
Brand
Axcent Acrylics
Company
GARRECO, LLC
Model
3018001
Catalog number
3018001
Device description
DNT BASE REPR PINK SC 1 LB
Published
2016-09-25
Public version status
Update
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
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79330180011PackageHIBCC4In Commercial Distribution
D79330180010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Regulatory Flags#

DUNS number
364004762
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D79330101010Axcent Acrylics301010130101012016-09-25
D79330101050Axcent Acrylics301010530101052016-09-25
D79330101200Axcent Acrylics301012030101202016-09-25
D79330102010Axcent Acrylics301020130102012016-09-25
D79330102050Axcent Acrylics301020530102052016-09-25
D79330103010Axcent Acrylics301030130103012016-09-25
D79330103050Axcent Acrylics301030530103052016-09-25
D79330104010Axcent Acrylics301040130104012016-09-25
D79330104050Axcent Acrylics301040530104052016-09-25
D79330134010Axcent Acrylics301340130134012016-09-25
D79330134050Axcent Acrylics301340530134052016-09-25
D79330180050Axcent Acrylics301800530180052016-09-26
D79330188010Axcent Acrylics301880130188012016-09-25
D79330188050Axcent Acrylics301880530188052016-09-25
D79331001010Axcent Acrylics310010131001012016-09-25
D79331001050Axcent Acrylics310010531001052016-09-24
D79331002010Axcent Acrylics310020131002012016-09-25
D79331002050Axcent Acrylics310020531002052016-09-25
D79331003010Axcent Acrylics310030131003012016-09-25
D79331003050Axcent Acrylics310030531003052016-09-25

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Primary DI, Brand, Company table
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00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
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06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
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00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09