Top Quality Manufacturing Temporary Crown & Bridge Material - Fast and accurate bis-acryl composite for - TOP QUALITY MANUFACTURING, INC.

Duns Number:113630649

Device Description: Fast and accurate bis-acryl composite for temporary restorationsShade A3

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More Product Details

Catalog Number

12601103

Brand Name

Top Quality Manufacturing Temporary Crown & Bridge Material

Version/Model Number

12601103

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

Yes

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

735b3d35-82d4-42df-8061-68cfa97b4378

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

December 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TOP QUALITY MANUFACTURING, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 26