FDA.report

Light Resin Plate

Primary DI
04582594041400
Brand
Light Resin Plate
Company
YAMAHACHI DENTAL MFG.,CO.
Model
2.2mm
Published
2022-08-09
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
true

Related Records

Product Codes

CodeName
EBHMaterial, Impression Tray, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04582594041400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04582594041400045825940414004582594041400

GMDN Terms

TermDefinition
Dental base plateA foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693430001
Device count
1
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
false
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 DIBrandModelCatalogPublished
D080SDGAC17PCSX17C0SHADE GUIDE ACSHADE GUIDE AC,17PCS,17C2025-11-19
D080SDGPX17PCSX17C0SHADE GUIDE CROWN PXSHADE GUIDE CROWN PX,17PCS,17C2025-11-19
04582276126500CROWN PXT61, B22020-06-02
04582276127125CROWN PXT51, B42020-06-11
04582276127149CROWN PXT61, B42020-06-11
04582276127422CROWN PXT41, C12020-06-12
04582276127460CROWN PXT61, C12020-06-12
04582276126401CROWN PXS51, B22020-06-02
04582276126449CROWN PXS71, B22020-06-02
04582276126456CROWN PXS81, B22020-06-02
04582276126463CROWN PXT41, B22020-06-02
04582276126470CROWN PXT41S, B22020-06-02
04582276126487CROWN PXT51, B22020-06-02
04582276126494CROWN PXT51S, B22020-06-02
04582276126517CROWN PXT61S, B22020-06-02
04582276127040CROWN PXS51, B42020-06-11
04582276127088CROWN PXS71, B42020-06-11
04582276127095CROWN PXS81, B42020-06-11
04582276127101CROWN PXT41, B42020-06-11
04582276127118CROWN PXT41S, B42020-06-11

Other Devices Sharing Product Codes

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