VarseoSmile Teeth - BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG

Duns Number:316483072

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More Product Details

Catalog Number

41147US

Brand Name

VarseoSmile Teeth

Version/Model Number

41147US

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)

Yes

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

PZY

Product Code Name

Additively Manufactured, Preformed, Resin Denture Tooth

Device Record Status

Public Device Record Key

d8d29d0f-a11a-4731-8e94-a0e623b45880

Public Version Date

November 04, 2021

Public Version Number

1

DI Record Publish Date

October 27, 2021

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