Catalog Number

-

Brand Name

Inspire

Version/Model Number

IC-WHCD100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183471,K183471

Product Code

NBL

Product Code Name

Laser, Fluorescence Caries Detection

Public Device Record Key

93c15dd4-1af7-40d2-ae43-5a18b63c264a

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

18800025400132

Quantity per Package

1

Contains DI Package

08800025400135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-