ProGlass Nine 179002-A3

GUDID 07290016787139

Dental Glass Ionomer Cement

SILMET LTD

Glass ionomer dental cement
Primary Device ID07290016787139
NIH Device Record Key5d2b22ea-8a2f-4c81-a23d-d3be62b83d00
Commercial Distribution StatusIn Commercial Distribution
Brand NameProGlass Nine
Version Model Number179002-A3
Catalog Number179002-A3
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
GS107290016787139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

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 Date2016-11-29

On-Brand Devices [ProGlass Nine]

07290016787283Dental Glass Ionomer Cement
07290016787276Dental Glass Ionomer Cement
07290016787139Dental Glass Ionomer Cement
07290016787122Dental Glass Ionomer Cement
07290016787115Dental Glass Ionomer Cement
07290016787108Dental Glass Ionomer Cement

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