FDA.reportPublic FDA data

Vertex-Dental BV

Primary DI
08720604633771
Brand
Vertex-Dental BV
Company
Vertex-Dental B.V.
Model
NDCMBL01000_01
Device description
For the manufacturing of crowns and bridges
Published
2024-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELJTEETH, ARTIFICIAL, POSTERIOR WITH METAL INSERT
ELKTEETH, ARTIFICIAL, BACKING AND FACING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELJTeeth, Artificial, Posterior With Metal InsertDental1
ELKTeeth, Artificial, Backing And FacingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720604633771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720604633771087206046337718720604633771

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
406389056
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
04260670160305optiprint I-B-T 385dentona AGELK2026-06-23
04260670160312optiprint I-B-T 385dentona AGELK2026-06-23
07506338322416ISOTEK, MDC DentalMDC DENTALELK2025-04-29
07506338322423ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322413ISOTEK, MDC DentalMDC DENTALELK2025-04-29
17506338322420ISOTEK, MDC DentalMDC DENTALELK2025-04-29
08720604633788Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633788Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633795Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633801Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633818Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELK2024-04-19
08720604633825Vertex-Dental BVVertex-Dental B.V.ELJ2024-04-19
08719425508924Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508924Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508948Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508955Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508962Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508979Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELJ2023-08-03
08719425508986Vertex-Dental BVVertex-Dental B.V.ELK2023-08-03
06975409642004CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15
06975409643001CerawhiteHangzhou Thales Medtech Co., Ltd.ELJ2023-05-15