FDA.report

Vertex-Dental BV

Primary DI
08719425506265
Brand
Vertex-Dental BV
Company
Vertex-Dental B.V.
Model
DCRPD0850000
Device description
Repair Material D / 08 50000gr
Published
2018-02-28
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
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications

CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08719425506265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08719425506265087194255062658719425506265

GMDN Terms

TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Sterilization Methods

Method

Regulatory Flags

DUNS number
406389056
Device count
1
DM exempt
false
Premarket exempt
false
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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