FDA.reportPublic FDA data

PRO3DURE GR-17 temporary

Primary DI
EPRCD1001433
Brand
PRO3DURE GR-17 temporary
Company
pro3dure medical GmbH
Model
1kg - A2
Published
2020-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201827000GR-17 Resin SystemPro3Dure Medical GmbH2020-11-05EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPRCD1001433PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4923749200500info@pro3dure.com

Regulatory Flags#

DUNS number
312947842
Device count
1
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
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02