FDA.reportPublic FDA data

INSTANT TRAY MIX

Primary DI
D65018346WHT0
Brand
INSTANT TRAY MIX
Company
LANG DENTAL MANUFACTURING CO., INC.
Model
PACKAGE WHITE
Catalog number
18346WHT
Device description
FAST CURING CUSTOM TRAY ACRYLIC RESIN POWDER AND 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
D65018346WHT0PrimaryHIBCC0

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