FDA.reportPublic FDA data

Axcent Acrylics

Primary DI
D79333030010
Brand
Axcent Acrylics
Company
GARRECO, LLC
Model
3303001
Catalog number
3303001
Device description
TRAY MATERIAL WHITE SC (1# EACH)
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
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D79333030011PackageHIBCC4In Commercial Distribution
D79333030010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression tray materialA material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.

Regulatory Flags#

DUNS number
364004762
Device count
1
Premarket exempt
true
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
D79330180010Axcent Acrylics301800130180012016-09-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D080XXTRR05KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
00197998216121Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216138Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216152Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216169Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216176Clarity™Solventum Orthodontics CorporationEBH2026-04-25
09359215000376DentaTRAY OrangeASIGA PTY LTDEBH2025-01-17
08800017902043Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
08800017902074Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
D248628000Surfactant 32ozHAGER WORLDWIDE, INC.EBH2023-07-13
D248628011Surfactant 8ozHAGER WORLDWIDE, INC.EBH2023-07-13
20386040012710COE®Gc America Inc.EBH2023-04-20
20386040012727COE®Gc America Inc.EBH2023-04-20
20386040012734COE®Gc America Inc.EBH2023-04-20
20386040012741COE®Gc America Inc.EBH2023-04-20
20386040012758COE®Gc America Inc.EBH2023-04-20
20386040012765COE®Gc America Inc.EBH2023-04-20
20386040012772COE®Gc America Inc.EBH2023-04-20
20386040012789COE®Gc America Inc.EBH2023-04-20
20386040012796COE®Gc America Inc.EBH2023-04-20
40386040001886COE®Gc America Inc.EBH2023-04-20