Bosworth Trim Plus - 1.5 oz PMMA Temp Resin Pwd, Shade 60 - Harry J Bosworth Company

Duns Number:014769301

Device Description: 1.5 oz PMMA Temp Resin Pwd, Shade 60

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More Product Details

Catalog Number

092193160

Brand Name

Bosworth Trim Plus

Version/Model Number

092193160

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

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Device Record Status

Public Device Record Key

8ec10d9f-a232-43c7-baf7-016bd47cd5fc

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HARRY J BOSWORTH COMPANY" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 248