ProVeneer 18PV01

GUDID 07290016787825

Dental Composite

SILMET LTD

Dental composite resin
Primary Device ID07290016787825
NIH Device Record Key11c25f51-a79d-42e3-adca-fe43aba79f05
Commercial Distribution StatusIn Commercial Distribution
Brand NameProVeneer
Version Model Number18PV01
Catalog Number18PV01
Company DUNS600071344
Company NameSILMET LTD
Device Count1
DM Exemptfalse
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 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
GS107290016787825 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-12-03
Device Publish Date2017-10-22

On-Brand Devices [ProVeneer]

07290016787825Dental Composite
07290015358804Dental Composite Restorative
07290015358798Dental Composite Restorative
07290015358781Dental Composite Restorative
07290015358774Dental Composite Restorative
07290015358767Dental Composite Restorative
07290015358750Dental Composite Restorative

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