SciPharm Support Core Build-Up 52-09

GUDID D801SP52091

Dental composite resin

Primary Device ID	D801SP52091
NIH Device Record Key	c5007f0e-39df-4326-bae3-0dd9fe0645d7
Commercial Distribution Status	In Commercial Distribution
Brand Name	SciPharm Support Core Build-Up
Version Model Number	SP 52-09
Catalog Number	52-09
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 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
Storage Environment Temperature	Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Issuing Agency	Device ID
HIBCC	D801SP52091 [Primary]

EBD	Coating, Filling Material, Resin

Steralize Prior To Use	false
Device Is Sterile	false

D801SP52091	Self-Curing Core Build-Up Restorative Paste/Paste Type. All Natural Shade. 50 grams.
D801SP50193N1	Self-Curing Core Build-Up Restorative Paste/Paste Material. 25 gram. Part A, Catalyst.
D801SP50191	Self-Curing Core Build-Up Restorative Paste/Paste Material. Contrast.