POUR-PLUS 1151116

GUDID D8451151116

POUR-PLUS, ORI, 454 g

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451151116
NIH Device Record Keybe3ed85c-dcfe-4218-bb49-d9f42076b7a5
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOUR-PLUS
Version Model Number1151116
Catalog Number1151116
Company DUNS202016064
Company NameDenplus Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
HIBCCD8451151116 [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 Number3
Public Version Date2018-07-06
Device Publish Date2018-04-30

On-Brand Devices [POUR-PLUS]

D8451152200POUR-PLUS LIQUID, 500 ml
D8451152100POUR-PLUS LIQUID, 250 ml
D8451151316POUR-PLUS, ORI, 11.3 kg
D8451151307POUR-PLUS, MDP, 11.3 kg
D8451151305SF0POUR-PLUS, LPI, WITHOUT FIBERS, 11.3 kg
D8451151305POUR-PLUS, LPI, 11.3 kg
D8451151302POUR-PLUS, LPL, 11.3 kg
D8451151300POUR-PLUS, CLR, 11.3 kg
D8451151216POUR-PLUS, ORI, 2.3 kg
D8451151207POUR-PLUS, MDP, 2.3 kg
D8451151205POUR-PLUS, LPI, 2.3 kg
D8451151202POUR-PLUS, LPL, 2.3 kg
D8451151200POUR-PLUS, CLR, 2.3 kg
D8451151116POUR-PLUS, ORI, 454 g
D8451151107POUR-PLUS, MDP, 454 g
D8451151105POUR-PLUS, LPI, 454 g
D8451151102POUR-PLUS, LPL, 454 g
D8451151100POUR-PLUS, CLR, 454 g

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