Catalog Number

000000-2165-387

Brand Name

Fluorescence Mode

Version/Model Number

000000-2165-387

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K171007

Product Code

NBL

Product Code Name

Laser, Fluorescence Caries Detection

Public Device Record Key

83050910-b412-4728-b6c3-f4b9931ff3e7

Public Version Date

August 21, 2019

Public Version Number

3

DI Record Publish Date

September 25, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-