Final Crown - BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Duns Number:316483072

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More Product Details

Catalog Number

SRI0205046

Brand Name

Final Crown

Version/Model Number

SRI0205046

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 09, 2022

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201668

Product Code Details

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Device Record Status

Public Device Record Key

8218395c-0f8e-4047-9214-270f1aa20660

Public Version Date

May 11, 2022

Public Version Number

2

DI Record Publish Date

February 04, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BEGO BREMER GOLDSCHLÄGEREI WILH. HERBST GMBH & CO.KG" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 89