Catalog Number

FLCTBL01

Brand Name

Custom Tray Resin

Version/Model Number

FLCTBL01

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

-

Product Code

EBH

Product Code Name

Material, Impression Tray, Resin

Public Device Record Key

2fdd3518-a945-4f87-bbfc-5c95c37e5679

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

10860002099320

Quantity per Package

8

Contains DI Package

00860002099323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case