Catalog Number

-

Brand Name

CamX SPECTRA Handpiece

Version/Model Number

J2310

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K150672

Product Code

NBL

Product Code Name

Laser, Fluorescence Caries Detection

Public Device Record Key

3c6cb2f0-a27e-468c-9d49-77ef40204fd2

Public Version Date

August 06, 2018

Public Version Number

1

DI Record Publish Date

July 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-