Catalog Number

644657

Brand Name

QHL75® Curing Light/Spectrum® 800 Curing Light

Version/Model Number

644657

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

K951425

Product Code

EBZ

Product Code Name

ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION

Public Device Record Key

37a1490f-c3c3-45f2-be1a-ab8d3a8c82d7

Public Version Date

November 15, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-