SciPharm Fastil Saliva-Cured Temporary Restorative 55-601

GUDID D801SP55601B1

Dental composite resin

Primary Device ID	D801SP55601B1
NIH Device Record Key	a31306f0-46a9-464a-b123-2dc437de5803
Commercial Distribution Status	In Commercial Distribution
Brand Name	SciPharm Fastil Saliva-Cured Temporary Restorative
Version Model Number	SP 55-601 B
Catalog Number	55-601
Company DUNS	096010525
Company Name	SCIENTIFIC PHARMACEUTICALS, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 15 Degrees Fahrenheit and 83 Degrees Fahrenheit
Storage Environment Temperature	Between 15 Degrees Fahrenheit and 83 Degrees Fahrenheit

Device Issuing Agency	Device ID
HIBCC	D801SP55601B1 [Primary]

EMA	Cement, Dental

Steralize Prior To Use	false
Device Is Sterile	false

D801SP55602T1	Fastfil - A Saliva-Cured Temporary Restorative Tube.
D801SP55601BSN1	Fastfil - A Saliva-Cured Temporary Restorative Jar. Non-Boxed. Spanish
D801SP55601BS1	Fastfil - A Saliva-Cured Temporary Restorative. Boxed. Spanish.
D801SP55601B1	Fastfil - A Saliva-Cured Temporary Restorative. Boxed.
D801SP556011	Fastfil - A Saliva-Cured Temporary Restorative.