Spherodon + O-130493

GUDID 07290012207594

Dental Amalgam Capsules

SILMET LTD

Dental amalgam
Primary Device ID07290012207594
NIH Device Record Key8c742593-55ec-442c-be55-51d77116513e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSpherodon +
Version Model NumberO-130493
Catalog NumberO-130493
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
GS107290012207594 [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 Date2016-10-26

Devices Manufactured by SILMET LTD

07290012207914 - ProFil Flow2019-01-08 Dental Composite Restorative
07290012207006 - Nogama 2018-12-28 Dental Amalgam Capsules
07290012207013 - Nogama 2018-12-28 Dental Amalgam Capsules
07290012207044 - Nogama 2018-12-28 Dental Amalgam Capsules
07290012207051 - Nogama 2018-12-28 Dental Amalgam Capsules
07290012207068 - Nogama 2018-12-28 Dental Amalgam capsules
07290012207075 - Nogama 2018-12-28 Dental Amalgam Capsules
07290012207112 - Nogama 2018-12-28 Dental Amalgam Capsules

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