Fluorilaq Squeeze Varnish Fresh Mint - Fluorilaq Squeeze Fresh Mint with 5 % Sodium - PASCAL COMPANY, INC.

Duns Number:009260217

Device Description: Fluorilaq Squeeze Fresh Mint with 5 % Sodium Fluoride Varnish, 9.5 mL squeezable bottle

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More Product Details

Catalog Number

10435

Brand Name

Fluorilaq Squeeze Varnish Fresh Mint

Version/Model Number

10435

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K030488

Product Code Details

Product Code

LBH

Product Code Name

Varnish, Cavity

Device Record Status

Public Device Record Key

a3665054-4264-4217-82fa-2f7cd6f9a667

Public Version Date

March 04, 2019

Public Version Number

1

DI Record Publish Date

January 30, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PASCAL COMPANY, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 34
2 A medical device with a moderate to high risk that requires special controls. 6
U Unclassified 57