Vertex-Dental BV

GUDID 08720604633887

For manufacturing of 3D printed individual impression trays

Vertex-Dental B.V.

Dental impression tray material
Primary Device ID08720604633887
NIH Device Record Key0de2e7a8-d155-4150-b0f5-af511df78a60
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertex-Dental BV
Version Model NumberNDTRPI01000_01
Company DUNS406389056
Company NameVertex-Dental B.V.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108720604633887 [Primary]

FDA Product Code

EBHMATERIAL, IMPRESSION TRAY, RESIN

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-29
Device Publish Date2024-04-19

On-Brand Devices [Vertex-Dental BV]

08719425505831Rapid Simplified 500 ML
08719425503585Self Curing 25000 ml
08719425503578Self Curing 200000 ml
08719425502021Castavaria 200000 ml
08719425501666Castavaria / 04 25000gr
08719425508467NextDent C&B MFH / T1
08719425508450NextDent C&B MFH / T1
08719425508443NextDent C&B MFH / T1
08719425508436NextDent C&B MFH / T1
08719425508429NextDent C&B MFH / N3
08719425508412NextDent C&B MFH / N3
08719425508405NextDent C&B MFH / N3
08719425508399NextDent C&B MFH / N2.5
08719425508382NextDent C&B MFH / N2.5
08719425508375NextDent C&B MFH / N2.5
08719425508368NextDent C&B MFH / N2
08719425508351NextDent C&B MFH / N2
08719425508344NextDent C&B MFH / N1.5
08719425508337NextDent C&B MFH / N1.5
08719425508320NextDent C&B MFH / N1
08719425508313NextDent C&B MFH / N1
08719425508306NextDent C&B MFH / BL
08719425508290NextDent C&B MFH / BL
08719425508283NextDent C&B MFH / BL
08719425508276NextDent C&B / A3.5
08719425508269NextDent C&B / A3.5
08719425508252NextDent C&B / A3.5
08719425508245NextDent C&B / A3.5
08719425508238NextDent C&B / A3.5
08719425508221NextDent C&B / A3.5
08719425508214NextDent C&B / A3.5
08719425508146NextDent Ortho Clear / Clear
08719425508139NextDent Ortho Clear / Clear
08719425508122NextDent Ortho Clear / Clear
08719425508115NextDent Ortho Clear / Clear
08719425508108NextDent Ortho Clear / Clear
08719425503295NextDent C&B MFH / N2
08719425503288NextDent C&B MFH / N1
08719425503264NextDent C&B MFH / N1.5
08719425501604Cold-Curing Pour-Type Dentrue Base Material
08719425508597NextDent Base / Pink
08719425508580NextDent Base / Pink
08719425508573NextDent Base / Pink
08719425508566NextDent Base / Pink
08719425508559NextDent Base / Pink
08719425508542NextDent Base / Pink
08719425508535NextDent Base / Pink
08719425508528NextDent Base / Pink
08719425508511NextDent Base / Pink
08719425508504NextDent Base / Pink

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.