FDA.reportPublic FDA data

PRO3DURE GR-21 Try-In

Primary DI
EPRCD1001602
Brand
PRO3DURE GR-21 Try-In
Company
pro3dure medical GmbH
Model
1kg ; Color:A2
Catalog number
D1001602
Device description
printodent GR-21 Try-In1kg ; Color:A2
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EEAPlate, Base, Shellac

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EEAPlate, Base, ShellacDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EPRCD1001602PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight

Sterilization Methods#

Method table
Method

Contacts#

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

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
06909412328068Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328075Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328082Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328099Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
06909412328105Try-inSHANDONG HUGE DENTAL MATERIAL CORPORATIONEEA2026-05-19
E239D359501FotoDent® TryInDreve Dentamid GmbHEEA2026-02-27
04260635981594RS VIVO Try-InDeltaMed GmbHEEA2025-07-29
EDEL162112103Delta Try-In XTDeltaMed GmbHEEA2025-07-29
EPRC0220003ACRY PRINT RU-003 Try-Inpro3dure medical GmbHEEA2025-03-31
EPRC768485UCAN Print Try-Inpro3dure medical GmbHEEA2025-03-31
D161280200Axio-BaseAxiodent Inc.EEA2024-10-02
08720604633832Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633849Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
08720604633856Vertex-Dental BVVertex-Dental B.V.EEA2024-04-19
D040711820Veri DENT TryinWHIP-MIX CORPORATIONEEA2024-04-18
EPRCD1001651printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001652printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
EPRCD1001653printodent GR-21.1 Try-In pro3dure medical GmbHEEA2023-10-16
00860010425411LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425428LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
00860010425435LuxCreo Dental Night Guard ResinLuxcreo IncEEA2023-07-31
D967130010Hiflex Base PlatesPREVEST DENPRO LIMITEDEEA2022-12-19
EPRCD1001603PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
EPRCD1001601PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-08-17
10850039704151Try-In 2Sprintray, Inc.EEA2022-02-28
04260635980207P pro Try-InDeltaMed GmbHEEA2022-02-11
04260635980542RS Try-InDeltaMed GmbHEEA2022-02-11
EDEL162111003Delta Try-InDeltaMed GmbHEEA2022-02-11
EDEL162112003Delta Try-InDeltaMed GmbHEEA2022-01-31
E22160491V-Print Try-InVOCO GmbHEEA2020-06-16