SciPharm Tempo-Rex Temporary/Intermediate Restoratives 50-603

GUDID D801SP50603N1

Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as a restorative for deciduous teeth, and for making temporary crowns, inlays, and onlays, endodontic stopping, and emergency restorations. Gray/Brown Shade. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental composite resin
Primary Device IDD801SP50603N1
NIH Device Record Keycfad9201-fe8e-477c-8c6b-110a11c13439
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Tempo-Rex Temporary/Intermediate Restoratives
Version Model NumberSP 50-603 N
Catalog Number50-603
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
HIBCCD801SP50603N1 [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 Date2016-08-03

On-Brand Devices [SciPharm Tempo-Rex Temporary/Intermediate Restoratives]

D801SP5060S1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50603N1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50603B1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50602N1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50602B1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50601N1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50601B1Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as
D801SP50601Tempo-Rex is a versatile light-cured material for making temporary/intermediate restorations, as

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