SciPharm Pit & Fissure Sealer Bonding Agent - Self-Cured Resin for Sealing Occlusal Fissures - SCIENTIFIC PHARMACEUTICALS, INC.

Duns Number:096010525

Device Description: Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etche Self-Cured Resin for Sealing Occlusal Fissures and Bonding Composite Restoratives to Etched Enamel. Clear. Part A. Boxed

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More Product Details

Catalog Number

54-011

Brand Name

SciPharm Pit & Fissure Sealer Bonding Agent

Version/Model Number

SP 54-011 B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K790788

Product Code Details

Product Code

EBC

Product Code Name

Sealant, Pit And Fissure, And Conditioner

Device Record Status

Public Device Record Key

488e3d74-ffb6-4e7a-830f-c6dabe3ec8c5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCIENTIFIC PHARMACEUTICALS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10
2 A medical device with a moderate to high risk that requires special controls. 476