ProCopper P-120150

GUDID 07290012207761

Dental Amalgam

SILMET LTD

Dental amalgam
Primary Device ID07290012207761
NIH Device Record Keyff2a40a8-d74f-4d54-949a-5291fa3c6756
Commercial Distribution StatusIn Commercial Distribution
Brand NameProCopper
Version Model NumberP-120150
Catalog NumberP-120150
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
GS107290012207761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EJJAlloy, Amalgam

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 Date2016-11-16

On-Brand Devices [ProCopper]

07290016787603Dental Amalgam Tablets
07290016787573Dental Amalgam Alloy
07290012207778Dental Amalgam
07290012207761Dental Amalgam
07290012207754Dental Amalgam Alloy
07290012207747Dental Amalgam Alloy

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