FDA.reportPublic FDA data

Vertex-Dental BV

Primary DI
08719425508641
Brand
Vertex-Dental BV
Company
Vertex-Dental B.V.
Model
NDTRPI01000
Device description
3D printing material for try-in devices
Published
2018-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

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
08719425508641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719425508641087194255086418719425508641

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis bite verification deviceA device intended to aid in the fabrication of a dental prosthesis (e.g., crown, bridge) by connecting the try-in prosthesis to the laboratory working model and to the patient for the purpose of verifying the fit and appearance of the final prosthesis before production. It is affixed with a dental prosthetic screw or dental prosthetic screw analogu(also known as guide pin). This is a single-use device.

Regulatory Flags#

DUNS number
406389056
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720604634167Vertex-DentalNDJTBSDP010002026-03-18
08720604634174Vertex-DentalNDJTBSLP010002026-03-18
08720604634181Vertex-DentalNDJTBSRP010002026-03-18
08720604634150Vertex-DentalNDJTBSLT010002025-02-22
08720604634198Vertex-DentalNDJTTHWH010002025-02-22
08720604634204Vertex-DentalNDJTTHYE010002025-02-22
08720604634129Vertex-DentalNDJTTHWH020002024-09-24
08720604634112Vertex-DentalNDJTBSPI020002024-09-09
08719425508153Vertex-Dental BVNDORBL010002018-03-14
08719425508160Vertex-Dental BVNOBEORBL005002018-03-14
08719425508177Vertex-Dental BVNOBEORBL010002018-03-14
08719425508184Vertex-Dental BVNOHKORBL010002018-03-14
08719425508207Vertex-Dental BVNOWHOCBL010002018-03-14
08719425508474Vertex-Dental BVNPNOORBL010002018-03-14
08719425508801CeramillNPAGORBL010002019-02-12
08720604633894Vertex-Dental BVNDORBL01000_012024-04-19
08719425509273Vertex-Dental BVNDOCCL01000_12023-08-03
08719425509396Vertex-Dental BVNDORBL01000_12023-08-03
08719425508191Vertex-Dental BVNOSHORBL010002018-03-14
08719425508108Vertex-Dental BVNDOCCL010002018-03-14

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
EPRCD1001602PRO3DURE GR-21 Try-In pro3dure medical GmbHEEA2022-09-12
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