Catalog Number

FLDLCL02

Brand Name

Dental LT Clear Resin V2

Version/Model Number

FLDLCL02

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

DYT

Product Code Name

Maintainer, Space Preformed, Orthodontic

Public Device Record Key

e04f12a0-ccb7-4473-9281-dd5a472ecebe

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2020

Package DI Number

10860002099337

Quantity per Package

8

Contains DI Package

00860002099330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case