CavityShield™ - 3M™ ESPE™ CavityShield™ 5% Sodium Fluoride - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ ESPE™ CavityShield™ 5% Sodium Fluoride Varnish Mixed Dentition Trial Pack - Bubble Gum 3M™ ESPE™ CavityShield™ 5% Sodium Fluoride Varnish Mixed Dentition Trial Pack - Bubble Gum Flavor, 12143

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More Product Details

Catalog Number

12143

Brand Name

CavityShield™

Version/Model Number

12143

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

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

-

Product Code Details

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Device Record Status

Public Device Record Key

dd2922af-ce49-483b-ac9e-87064b9c763f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 444
U Unclassified 7