SciPharm Pit & Fissure Sealer Bonding Agent 52-01

GUDID D801SP5201S1

Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. White. Spanish.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental pit/fissure sealant
Primary Device IDD801SP5201S1
NIH Device Record Key0954ca87-e640-430b-95aa-dfc181358fb2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSciPharm Pit & Fissure Sealer Bonding Agent
Version Model NumberSP 52-01 S
Catalog Number52-01
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 73 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD801SP5201S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBCSealant, Pit And Fissure, And Conditioner

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 Pit & Fissure Sealer Bonding Agent]

D801SP5601S1Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
D801SP5601CH1Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
D801SP56011N1Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
D801SP56011B1Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
D801SP56011Light-Cured Resin for Sealing Occlusal Fissures and for Bonding Composite Restoratives to Etched
D801SP5401S1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP54011N1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP54011B1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP54011Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP5301S1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP530111Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP53011Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP52091N1Self-Curing Core Build-Up Restorative Paste/Paste Type. All Natural Shade. 50 grams. Part A.
D801SP5201S1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP52012B1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP520121Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP52011B1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP520111Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP52011Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP5101S1Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam
D801SP51011Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enam

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