SciPharm Fluoroseal Cavity Liner 75-031

GUDID D801SP750351

Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations. Also Provide Protection Against Irritants from Restoratives or Auxiliary Materials. Dentin Shade Syringe. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental cavity varnish
Primary Device IDD801SP750351
NIH Device Record Key4aac05dd-ce67-4eab-bafc-a215037f0028
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Fluoroseal Cavity Liner
Version Model NumberSP 75-035
Catalog Number75-031
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
HIBCCD801SP750351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

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 Date2016-08-11

On-Brand Devices [SciPharm Fluoroseal Cavity Liner]

D801SP75131N1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75131BS1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75131B1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75131Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP7503S1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75036B1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75035Z1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75035BS1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75035B1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP750351Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75031NB1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75031BS1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75031B1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP75031Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations
D801SP72036B1Fluoroseal is a Light-Cured Cavity Liner used for Building the Cavity Floor in Deep Restorations

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