FDA.report

Vertex-Dental BV

Primary DI
08719425505282
Brand
Vertex-Dental BV
Company
Vertex-Dental B.V.
Model
HDARSP0825000
Device description
HD Rapid Simplified / 08 25000gr
Published
2018-02-14
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
08719425505282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08719425505282087194255052828719425505282

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
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00842326128095DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128101DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128118DuraflexThe Myerson Company LimitedEBI2026-05-26
00842326128125DuraflexThe Myerson Company LimitedEBI2026-05-26
00815967025917RodinPac-Dent, Inc.EBI2026-03-23
00815967029342RodinPac-Dent, Inc.EBI2026-03-23
00815967029359RodinPac-Dent, Inc.EBI2026-03-23
00815967029366RodinPac-Dent, Inc.EBI2026-03-23
00815967029373RodinPac-Dent, Inc.EBI2026-03-23
06971437942314UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942321UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942338UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942352UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942376UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942383UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942390UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942406UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942413UltraPrint Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-05
06971437942192UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942208UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942215UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942222UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942239UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942246UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942253UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942260UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942277UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942284UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942291UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04
06971437942307UltraPrint-Dental Denture UVGUANGZHOU HEYGEARS IMC.INCEBI2026-03-04