FDA.reportPublic FDA data

INSTANT TRAY MIX LIQUID

Primary DI
D6501808R0
Brand
INSTANT TRAY MIX LIQUID
Company
LANG DENTAL MANUFACTURING CO., INC.
Model
19 L
Catalog number
1808R
Device description
FAST CURING CUSTOM TRAY ACRYLIC RESIN LIQUID
Published
2017-12-01
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
D6501808R0PrimaryHIBCC0

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
005185798
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
D650PTA10PULSETEMPSHADE A1 50 ML CARTRIDGE 10:1PTA12026-01-15
D650PTA20PULSETEMPSHADE A2 50 ML CARTRIDGE 10:1PTA22026-01-15
D650PTA30PULSETEMPSHADE A3 50 ML CARTRIDGE 10:1PTA32026-01-15
D6501508YEL0CONTEMPORARY ORTHO-JET LIQUID19 L YELLOW1508YEL2017-12-01
D6500270C0ORTHO-JET CRYSTAL POWDER11.3 KG0270C2023-06-27
D6500934F10FLEXACRYL HARDPOUND PACKAGE F10934F12023-06-27
D6500950CLR0FLEXACRYL2.7 KG CLEAR0950CLR2023-06-27
D6501070P10TEMPO POWDER11.3 KG P11070P12023-06-27
D6501330LS0ORTHO-JET POWDER1 LB LOW SLUMP1330LS2023-06-27
D6501356PT0ORTHO-JETFIVE POUND PACKAGE PINK TINT1356PT2023-06-27
D6501480LI0JET TOOTH SHADE POWDER45.4 KG SHADE LIGHT INCISAL1480LI2023-06-27
D65038H0DRK0JET SET-4 TOOTH SHADE POWDER250 GRAMS SHADE DARK38H0DRK2016-09-01
D6504720F20JET SET-4 DENTURE REPAIR100 GRAM F24720F22022-10-20
D6504720P10JET SET-4 DENTURE REPAIR100 GRAM P14720P12022-10-20
D6504723F20JET SET-4 DENTURE REPAIRPROFESSIONAL PACKAGE F24723F22022-10-20
D6504723P10JET SET-4 DENTURE REPAIRPROFESSIONAL PACKAGE P14723P12022-10-20
D6504730F20JET SET-4 DENTURE REPAIR454 GRAM F24730F22022-10-20
D6504730P10JET SET-4 DENTURE REPAIR454 GRAMS P14730P12022-10-20
D6504734F20JET SET-4 DENTURE REPAIRPOUND PACKAGE F24734F22022-10-20
D6504734P10JET SET-4 DENTURE REPAIRPOUND PACKAGE P14734P12022-10-20

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