Catalog Number

1036516

Brand Name

Baltic Denture System BDLoad

Version/Model Number

Baltic Denture System BDLoad Tooth Shade Sw7 PLSEbm6DFs B1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

EKO

Product Code Name

Denture Preformed (Partially Prefabricated Denture)

Public Device Record Key

3be407b4-57dc-446f-99c6-a35fe17fd3e7

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-