SciPharm InterCem Temporary Cement 55-40

GUDID D801SP55401

InterCem - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants and Conventional Crown and Bridge Restorations.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin
Primary Device IDD801SP55401
NIH Device Record Keyebf5bd61-19d5-4511-821d-870fca744314
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm InterCem Temporary Cement
Version Model NumberSP 55-40
Catalog Number55-40
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

Phone909-595-9922
EmailDenise@scipharm.com
Phone909-595-9922
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
HIBCCD801SP55401 [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 InterCem Temporary Cement]

D801SP55411InterCem - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants
D801SP55401InterCem - A Resin-Based Provisional Luting Agent Designed for Temporary Cementation of Implants

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