SciPharm Fastil Saliva-Cured Temporary Restorative 55-602

GUDID D801SP55602T1

Fastfil - A Saliva-Cured Temporary Restorative Tube.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin
Primary Device IDD801SP55602T1
NIH Device Record Keyefb30eef-855e-4695-b86a-5aaaff629d74
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Fastil Saliva-Cured Temporary Restorative
Version Model NumberSP 55-602 T
Catalog Number55-602
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 15 Degrees Fahrenheit and 83 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Fahrenheit and 83 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP55602T1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

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 Date2016-08-09

On-Brand Devices [SciPharm Fastil Saliva-Cured Temporary Restorative]

D801SP55602T1Fastfil - A Saliva-Cured Temporary Restorative Tube.
D801SP55601BSN1Fastfil - A Saliva-Cured Temporary Restorative Jar. Non-Boxed. Spanish
D801SP55601BS1Fastfil - A Saliva-Cured Temporary Restorative. Boxed. Spanish.
D801SP55601B1Fastfil - A Saliva-Cured Temporary Restorative. Boxed.
D801SP556011Fastfil - A Saliva-Cured Temporary Restorative.

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