Self Etching primer - The Reliance S.E.P.™ is a self etching primer Kit - RELIANCE ORTHODONTIC PRODUCTS INC

Duns Number:113170088

Device Description: The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P Starter Kit – Ref# SEPPROS.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD

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More Product Details

Catalog Number

SEPPRO

Brand Name

Self Etching primer

Version/Model Number

SEPPRO

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

-

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

K071688

Product Code Details

Product Code

KLE

Product Code Name

Agent, Tooth Bonding, Resin

Device Record Status

Public Device Record Key

289ec8fd-c88f-441b-8f9d-322c26030db8

Public Version Date

July 24, 2020

Public Version Number

4

DI Record Publish Date

August 01, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 73
2 A medical device with a moderate to high risk that requires special controls. 279