FDA.reportPublic FDA data

printodent GR-18.2 IB

Primary DI
EPRCD1001464
Brand
printodent GR-18.2 IB
Company
pro3dure medical GmbH
Model
1000g; clear transparent
Catalog number
D1001464
Published
2023-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
EPRCD1001464PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
312947842
Device count
1
Premarket exempt
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
EPRCD1001501printodent GR-19.1 OAclear-transparent, 1000gD10015012023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIocean-blue, 1000gD10015042023-08-29
EPRC66100851dima Print Denture Base 21kg - Pink661008512025-07-31
EPRC66100849dima Print Denture Base 21kg - Original Pink661008492025-07-31
EPRC66100850dima Print Denture Base 21kg - Reddish-Pink661008502025-07-31
EPRC0220001A2ACRY PRINT RU-001 Temporary1000g ; A20220001A22025-03-31
EPRC0220001A3ACRY PRINT RU-001 Temporary1000g ; A30220001A32025-03-31
EPRC0220003ACRY PRINT RU-003 Try-In1000g ; A202200032025-03-31
EPRC0220004ACRY PRINT RU-004 Denture HI1000g ; Orange-Pink02200042025-03-31
EPRC0220005ACRY PRINT RU-005 Guide1000g ; Clear-Transparent02200052025-03-31
EPRC768345UCAN Print Base1000g ; color 337683452025-03-31
EPRC768485UCAN Print Try-In1000g ; A27684852025-03-31
EPRC768486UCAN Print Splint1000g ; Transparent7684862025-03-31
EPRC768507UCAN Print Tray1000g ; Light-Pink7685072025-03-31
EPRC6550IMPRIMO LC Splint comfortclear-transparent, 1000g65502024-05-06
EPRC6575IMPRIMO LC Splint comfort MSIocean-blue, 1000g65752024-05-06
EPRCD1000300PRO3DURE GR-1guide1kg - clear-transparent 2022-08-17
EPRCD1000808printodent GR-10 guide I MSI 1000g ; ocean-blueD10008082024-08-20
EPRCA0010200otosil IS-28 double cartridges of 2 x 25 mlA00102002023-10-18
EPRCA0011000otosil PS-12 x 300g ; Orange - WhiteA00110002023-10-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
06975527188408MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
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