Vertex-Dental

GUDID 08720604634037

For the manufacturing of full or partial removable denture bases

Vertex-Dental B.V.

Dental appliance fabrication material, resin
Primary Device ID08720604634037
NIH Device Record Key2f736a49-b020-421f-804f-60f33c57bd8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertex-Dental
Version Model NumberNDBS0701000_01
Company DUNS406389056
Company NameVertex-Dental B.V.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
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
GS108720604634037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-28
Device Publish Date2023-11-20

On-Brand Devices [Vertex-Dental]

08719425509587Ceramill Denture 3D+ / Classic Pink
08719425509570NextDent Denture 3D+ / Classic Pink
08720604634051For the manufacturing of full or partial removable denture bases
08720604634044For the manufacturing of full or partial removable denture bases
08720604634037For the manufacturing of full or partial removable denture bases
08720604634020For the manufacturing of full or partial removable denture bases
08720604634112For the manufacturing of full or partial removable denture bases
08720604634129For the manufacturing of full or partial removable denture bases

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