Catalog Number

D3

Brand Name

ORTOLUX TOP

Version/Model Number

ANTERIOR TEETH 1x6

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

K070591

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

c8ac2bca-68b4-4f23-a9d2-57a0d5e367f4

Public Version Date

December 17, 2021

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-