Catalog Number

-

Brand Name

Trilor

Version/Model Number

FDS16PP

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

K173643

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

4429a110-1e17-4990-8e4b-3d19b7dd2866

Public Version Date

September 21, 2021

Public Version Number

1

DI Record Publish Date

September 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-