Vanish™ - 3M™ ESPE™ Vanish™ 5% Sodium Fluoride White - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ ESPE™ Vanish™ 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate (TCP) 50 Pac 3M™ ESPE™ Vanish™ 5% Sodium Fluoride White Varnish with Tri-Calcium Phosphate (TCP) 50 Pack - Mint Flavor, 12149M

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More Product Details

Catalog Number

12149M

Brand Name

Vanish™

Version/Model Number

12149M

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

93f5146e-f5ff-48ce-a6ea-5d3aa6a0603f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50605861013319

Quantity per Package

6

Contains DI Package

30605861013315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"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