Etchant Gel - Etchant Gel is 37% phosphoric acid (H3PO4) - Xemax Surgical Products Inc

Duns Number:804495695

Device Description: Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on ename Etchant Gel is 37% phosphoric acid (H3PO4) polymer-thickened and intended for use on enamel to prepare the surface for bonding. 9g etch in bottle.

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More Product Details

Catalog Number

CLEG

Brand Name

Etchant Gel

Version/Model Number

CLEG

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

K875313

Product Code Details

Product Code

KLE

Product Code Name

AGENT, TOOTH BONDING, RESIN

Device Record Status

Public Device Record Key

7d9904b9-e900-4967-ae3a-92d31070aa38

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 22, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"XEMAX SURGICAL PRODUCTS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 7