FDA.reportPublic FDA data

Vertex-Dental

Primary DI
08720604634204
Brand
Vertex-Dental
Company
Vertex-Dental B.V.
Model
NDJTTHYE01000
Device description
For the manufacturing of artificial teeth, crowns or bridges
Published
2025-02-22
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
EBGCROWN AND BRIDGE, TEMPORARY, RESIN
PZYAdditively manufactured, preformed, resin denture tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241071000NextDent Jet Denture Base; NextDent Jet Denture TeethVertex-Dental B.V.2024-09-04EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08720604634204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08720604634204087206046342048720604634204

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
406389056
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720604634235Vertex-Dental BVCHC20P05GDS500002026-09-24
08720604634242Vertex-Dental BVCHC20P20GDS500002026-09-24
08720604634167Vertex-DentalNDJTBSDP010002026-03-18
08720604634174Vertex-DentalNDJTBSLP010002026-03-18
08720604634181Vertex-DentalNDJTBSRP010002026-03-18
08720604634150Vertex-DentalNDJTBSLT010002025-02-22
08720604634198Vertex-DentalNDJTTHWH010002025-02-22
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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