D814UBAR87D0 UBAR87D

GUDID D814UBAR87D0

2.25 kg ProTech UBAR Tooth Acrylic Powder Shade 87

PROTECH PROFESSIONAL PRODUCTS INC

Denture reliner, elastic, short-term
Primary Device IDD814UBAR87D0
NIH Device Record Key638c0227-73ae-4e69-991a-934c092032f7
Commercial Distribution StatusIn Commercial Distribution
Brand NameD814UBAR87D0
Version Model NumberUBAR87D
Catalog NumberUBAR87D
Company DUNS117374900
Company NamePROTECH PROFESSIONAL PRODUCTS 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
HIBCCD814UBAR87D0 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-08-12
Device Publish Date2019-08-02

Devices Manufactured by PROTECH PROFESSIONAL PRODUCTS INC

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D814UBARV11GD0 - ProTech UBAR2019-11-07 ProTech UBAR Powder Shade 506RR 160 g
D814PLUS12AC0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Kit Shade 1060LL - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
D814PLUS12AD0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Kit Shade 506RR - 440 g ProTech Plus Powder and 240 ml ProTech Plus Monomer
D814PLUS12GC0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Shade 1060LL 440 gram Powder Only
D814PLUS12GD0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Shade 506RR 440 g Powder Only
D814PLUS13GC0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Shade 1060LL 2.25 kg Powder Only
D814PLUS13GD0 - ProTech Plus Hard Reline and Repair Acrylic2019-10-02 ProTech Plus Shade 506RR 2.25 kg Powder Only

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