SciPharm CuRay Fil Light Cure Composite Resin 50-110

GUDID D801SP50110N1

Visible Light-Cured Dentin Enamel Bonding Agent, Resin Based. Non-Boxed

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin
Primary Device IDD801SP50110N1
NIH Device Record Key95535d95-a128-4a38-97f7-497b98a067b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm CuRay Fil Light Cure Composite Resin
Version Model NumberSP 50-110 N
Catalog Number50-110
Company DUNS096010525
Company NameSCIENTIFIC PHARMACEUTICALS, 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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-634-3047
EmailDenise@scipharm.com
Phone800-634-3047
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 75 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP50110N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

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 Date2016-07-28

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D801SP50115CBS201Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, 20 Carpules
D801SP50115CB1Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, Carpule.
D801SP50115C1Visible Light-Cured Restorative, Resin Based. Shade A3.5, Carpule
D801SP50115BS1Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed, Spanish.
D801SP50115B1Visible Light-Cured Restorative, Resin Based. Shade A3.5, Boxed.
D801SP50114N1Visible Light-Cured Restorative, Resin Based. Shade A3, Non-Boxed
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D801SP50114CB1Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed, Carpule
D801SP50114C1Visible Light-Cured Restorative, Resin Based. Shade A3, Carpule
D801SP50114BS1Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed, Spanish
D801SP50114B1Visible Light-Cured Restorative, Resin Based. Shade A3, Boxed
D801SP50113N1Visible Light-Cured Restorative, Resin Based. Shade A4, Non-Boxed
D801SP50113CB1Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed, Carpule
D801SP50113C1Visible Light-Cured Restorative, Resin Based. Shade A4, Carpule
D801SP50113BS1Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed, Spanish
D801SP50113B1Visible Light-Cured Restorative, Resin Based. Shade A4, Boxed.
D801SP50112N1Visible Light-Cured Restorative, Resin Based. Shade C4, Non-Boxed
D801SP50112CB1Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed, Carpule
D801SP50112C1Visible Light-Cured Restorative, Resin Based. Shade C4, Carpule
D801SP50112BS1Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed, Spanish
D801SP50112B1Visible Light-Cured Restorative, Resin Based. Shade C4, Boxed
D801SP50110N1Visible Light-Cured Dentin Enamel Bonding Agent, Resin Based. Non-Boxed
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D801SP50109B1Visible Light-Cured Bonding Agent, Resin Based. Boxed
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D801SP50107BS1Visible Light-Cured Restorative, Resin Based. Shade B3, Boxed, Spanish
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D801SP50106CBS201Visible Light-Cured Restorative, Resin Based. Shade D3, Boxed, 20 Carpules
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