FDA.reportPublic FDA data

SR Ivolen

Primary DI
07615208455120
Brand
SR Ivolen
Company
IVOCLAR VIVADENT AKTIENGESELLSCHAFT
Model
530363
Catalog number
530363
Device description
SR Ivolen Powder 2x500 g
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
DIVO5303631PreviousHIBCC0
07615208421071PrimaryGS10
07615208455120Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07615208421071076152084210717615208421071
07615208455120076152084551207615208455120

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

Regulatory Flags#

DUNS number
448015938
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
DVIV687778WW0Adhese Universal DC687778WW687778WW2026-03-17
DVIV687779WW0Adhese Universal DC687779WW687779WW2026-03-17
07615208482416OptraSculpt759593AN759593AN2026-03-13
07615208482423OptraSculpt759595AN759595AN2026-03-13
07615208590500OptraSculpt760474AN760474AN2026-03-13
07615208590678OptraSculpt760475AN760475AN2026-03-13
07615208590494OptraSculpt760476AN760476AN2026-03-13
07615208482768OptraSculpt760477AN760477AN2026-03-13
07615208315349Modeling Liquids Ceramic7015887015882026-03-05
07615208338027Modeling Liquids Ceramic6733746733742026-03-05
07615208338058Modeling Liquids Ceramic6733716733712026-03-05
07615208374292Modeling Liquids Ceramic6053666053662026-03-05
07615208488401OptraSculpt683100AN683100AN2026-01-15
07615208445596OptraSculpt683069AN683069AN2026-01-15
07615208445602OptraSculpt683068AN683068AN2026-01-15
07615208486254OptraSculpt639793AN639793AN2026-01-15
07615208445947OptraSculpt639792AN639792AN2026-01-15
07615208590296Tetric CAD6921946921942026-01-13
07615208590258Tetric CAD6921936921932026-01-13
07615208590265Tetric CAD6921926921922026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08906139320670Taglus Model ResinLAXMI DENTAL LIMITEDEBH2026-01-09
08906139320694Taglus Model Resin SLAXMI DENTAL LIMITEDEBH2026-01-09
08906139323473Taglus Model Resin OdourlessLAXMI DENTAL LIMITEDEBH2026-01-09
06975338701292SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
06975338701308SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBH2025-12-09
00850061175151H-0600 ResinFORMLABS OHIO INC.EBH2025-12-01
EDET047221RS VIVO IBT 1000gDETAX GmbHEBH2025-11-20
E235S3DMR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
E235S3DOR0DentaprintSHOFU DENTAL CORPORATIONEBH2025-08-26
07701126901075Portux 3D Printing Resin Basic Gray x 500gPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901204Portux 3D Printing Resin Dental ModelsPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
07701126901235Portux 3D Printing Resin Model 2.0PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBH2025-08-11
04260635981587RS VIVO TrayDeltaMed GmbHEBH2025-07-29
EDEL162162003Delta Tray RoseDeltaMed GmbHEBH2025-07-29
D7091084045M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084046M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084047M-PRINT TryInMerz Dental GmbHEBH2025-07-08
D7091084048M-PRINT TryInMerz Dental GmbHEBH2025-07-08
16978499313042RAYFORM TechnologyZiyang Rayform Technology Co., Ltd.EBH2025-05-09
EPRC768507UCAN Print Traypro3dure medical GmbHEBH2025-03-31
E239D4210ZS1DrufoplastDreve Dentamid GmbHEBH2025-03-21
06975471800036PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800043PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800050PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800067PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800074PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800081PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800098PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800104PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26
06975471800111PionextShenzhen Piocreat 3D Technology Co., LtdEBH2024-12-26