Catalog Number

-

Brand Name

Temporary CB B1

Version/Model Number

FLTCB101US

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193553,K193553

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

a4f721f6-5679-4548-9b16-bb9d9fc50bef

Public Version Date

October 29, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

EBGOFLTCB101US2

Quantity per Package

1

Contains DI Package

EBGOFLTCB101US1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box