Shatkin FIRST Resin Cement Self-Cure SFRC

GUDID D801SFRC1

Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Resin Adhesive. 6 gram Dual Barrel. Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Glass ionomer dental cement
Primary Device IDD801SFRC1
NIH Device Record Key0102f0c9-7810-4312-bfcf-88e9dd65287a
Commercial Distribution Discontinuation2018-02-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameShatkin FIRST Resin Cement Self-Cure
Version Model NumberSFRC
Catalog NumberSFRC
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

Phone9095959922
EmailDenise@scipharm.com
Phone9095959922
EmailDenise@scipharm.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SFRC1 [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 Date2018-01-31

On-Brand Devices [Shatkin FIRST Resin Cement Self-Cure]

D801SFRCB1Shatkin First - An Advanced Eugenol Free Solution for Permanent Crown and Bridge Cementation. R
D801SFRC1Shatkin First - An Advanced Eugenol Free Solution to Temporary Crown and Bridge Cementation. Re

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