Catalog Number

56739018

Brand Name

Basic 6, A2 / A11, CE

Version/Model Number

56739018

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 10, 2022

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000213

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

b563e51f-37bd-49fe-83b0-ccd90ea77a19

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-