Catalog Number

-

Brand Name

Trilor Arch

Version/Model Number

TA 5.5

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

Yes

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

6f6da60d-35e6-4f92-9293-0fe3b700fe60

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

March 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-