Catalog Number

1036345

Brand Name

Baltic Denture System BDLoad

Version/Model Number

Baltic Denture System BDLoad High Impact lower Mm6 PLSEum2DFm BL4ECO dark pink

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

5a3796ff-722f-4815-b678-d66e7efbab57

Public Version Date

October 09, 2019

Public Version Number

1

DI Record Publish Date

October 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-