FDA.report

C-PLAST

Primary DI
E1996742721
Brand
C-PLAST
Company
Candulor AG
Model
674272
Catalog number
674272
Device description
C-Plast Monomer 500ml
Published
2023-11-15
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

Related Records

Product Codes

CodeName
EBHMATERIAL, IMPRESSION TRAY, RESIN

Product Code Classifications

CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E1996742721PrimaryHIBCC0

GMDN Terms

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

Regulatory Flags

DUNS number
480467422
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
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 DIBrandModelCatalogPublished
07630813462158TCR Mono7561977561972025-05-20
07630813462172TCR Mono7561997561992025-05-20
07630813462189TCR Mono7562007562002025-05-20
07630813462196TCR Mono7562017562012025-05-20
07630813462219TCR Mono7562037562032025-05-20
07630813462257TCR Multi7562177562172025-05-20
07630813462288TCR Multi7562207562202025-05-20
07630813462318TCR Multi7562237562232025-05-20
07630813462325TCR Multi7562247562242025-05-20
07630813439020Candulor Preference5784495784492023-11-16
07630813439075Candulor Preference5784445784442023-11-16
07630813439082Candulor Preference5784415784412023-11-16
07630813439136Candulor Preference5784365784362023-11-16
07630813439150Candulor Preference5784345784342023-11-16
07630813439167Candulor Preference5784335784332023-11-16
07630813439174Candulor Preference5784325784322023-11-16
07630813439204Candulor Preference5784295784292023-11-16
07630813439235Candulor Preference5784265784262023-11-16
07630813439242Candulor Preference5784235784232023-11-16
07630813439259Candulor Preference5784225784222023-11-16

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
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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