Silk Line Refill Cartridge

GUDID 10852253006141

Refill Cartridge for Silk Line Denture Reliner

J. MORITA U.S.A., INC

Denture reliner, soft, professional
Primary Device ID10852253006141
NIH Device Record Keyc17389f0-934e-4565-ae86-e9b5ef2baddc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilk Line Refill Cartridge
Version Model Number28100200
Company DUNS021866033
Company NameJ. MORITA U.S.A., INC
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110852253006141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-01-28
Device Publish Date2016-09-22

On-Brand Devices [Silk Line Refill Cartridge]

18522530060143Refill Cartridge for Silk Line Denture Reliner
10852253006141Refill Cartridge for Silk Line Denture Reliner

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