Spherodon + 139492

GUDID 07290012207679

Dental Amalgam Alloy

SILMET LTD

Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam Dental amalgam
Primary Device ID07290012207679
NIH Device Record Key6d65768e-fdf7-4c5c-86c7-2166918c034d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpherodon +
Version Model Number139492
Catalog Number139492
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
GS107290012207679 [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 Date2018-12-28
Device Publish Date2016-11-09

On-Brand Devices [Spherodon +]

07290016787733Dental Amalgam Capsules
07290012207686Dental Amalgam Alloy
07290012207679Dental Amalgam Alloy
07290012207662Dental Amalgam Alloy
07290012207655Dental Amalgam Alloy
07290012207648Dental Amalgam Alloy
07290012207631Dental Amalgam Alloy
07290012207624Dental Amalgam Alloy
07290012207617Dental Amalgam Alloy
07290012207600Dental Amalgam Capsules
07290012207587Dental Amalgam Capsules
07290012207570Dental Amalgam Capsules
07290012207563Dental Amalgam Capsules
07290012207556Dental Amalgam Capsules
07290012207549Dental Amalgam Capsules
07290012207532Dental Amalgam Capsules
07290012207525Dental Amalgam Capsules
07290012207518Dental Amalgam Capsules

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