FDA.reportPublic FDA data

DURALAY - CLEAR

Primary DI
D9472244C1
Brand
DURALAY - CLEAR
Company
Reliance Dental Manufacturing Co Inc
Model
2244-C
Device description
INLAY PATTERN RESIN/2 OZ. POWDER / 2 OZ. LIQUID(56 GR POWDER / 60 ML LIQUID)
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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
D9472244C1PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
708-597-6694service@reliancedental.net

Regulatory Flags#

DUNS number
005139159
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D9471401Durabase - Pink14012023-01-13
D9471506Durabase Soft - Pink15062023-01-13
D9471601Duraliner II - Pink16012023-01-13
D9472150DURALAY II QUICK CURE LAB PATTER RESIN - PINK21502023-01-13
D9472243DURALAY COMBINATION PKG. - Red22432023-01-13
D9472249D1DURALAY - RED2249D2023-01-13
D9472249DB1DURALAY - BLUE2249D-B2023-01-13
D9472503DURALAY – Temporary Crown & Bridge Kit25032023-01-13
D9472706DURASEAL27062023-01-13
D9472709DURASEAL27092023-01-13
D9471701Dura Rely-A-Soft Complete Package - Pink17012022-08-23
D9471701C1Dura Rely-A-Soft Complete Package - Clear1701-C2022-08-23
D9471706Dura Rely-A-Soft Economy Package - Pink17062022-08-23
D9471706C1Dura Rely-A-Soft Economy Package - Clear1706-C2022-08-23
D9471801Dura Conditioner Complete Package - White18012022-08-23
D9471801P1Dura Conditioner Complete Package - Pink1801-P2022-08-23
D9471805Dura Conditioner Bulk Package - White18052022-08-23
D9471805P1Dura Conditioner Bulk Package - Pink1805-P2022-08-23
D9471401C1Durabase - Clear1401-C2022-08-03
D9471506C1Durabase Soft - Clear1506-C2022-08-03

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