Baltic Denture System BDLoad - Baltic Denture System BDLoad Tooth Shade UK Mm7 - Merz Dental GmbH

Duns Number:324914910

Device Description: Baltic Denture System BDLoad Tooth Shade UK Mm7 PLSEum2DFm B1

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More Product Details

Catalog Number

1036437

Brand Name

Baltic Denture System BDLoad

Version/Model Number

Baltic Denture System BDLoad Tooth Shade UK Mm7 PLSEum2DFm B1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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 Details

Product Code

EKO

Product Code Name

Denture Preformed (Partially Prefabricated Denture)

Device Record Status

Public Device Record Key

16b10ef3-cabd-4216-8d58-0a43f694bace

Public Version Date

March 12, 2020

Public Version Number

1

DI Record Publish Date

March 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERZ DENTAL GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 12495
U Unclassified 15