FDA.report

Vertex-Dental BV

Primary DI
08719425500072
Brand
Vertex-Dental BV
Company
Vertex-Dental B.V.
Model
NPPLSGOR01000
Device description
NextDent SG/ Orange
Published
2017-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
NDPAccessories, implant, dental, endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08719425500072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08719425500072087194255000728719425500072

GMDN Terms

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

Regulatory Flags

DUNS number
406389056
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08720604634150Vertex-DentalNDJTBSLT010002025-02-22
08720604634198Vertex-DentalNDJTTHWH010002025-02-22
08720604634204Vertex-DentalNDJTTHYE010002025-02-22
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
08720604634129Vertex-DentalNDJTTHWH020002024-09-24
08720604634112Vertex-DentalNDJTBSPI020002024-09-09
08720604633771Vertex-Dental BVNDCMBL01000_012024-04-19
08720604633788Vertex-Dental BVNDCMN101000_012024-04-19
08720604633795Vertex-Dental BVNDCMN1.501000_012024-04-19
08720604633801Vertex-Dental BVNDCMN201000_012024-04-19
08720604633818Vertex-Dental BVNDCMN2.501000_012024-04-19
08720604633825Vertex-Dental BVNDCMN301000_012024-04-19
08720604633832Vertex-Dental BVNDTRPI01000_012024-04-19
08720604633849Vertex-Dental BVNDTRPI01000_012024-04-19

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