Catalog Number

761381

Brand Name

Ceramill

Version/Model Number

A-Temp A3,5 B55

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"

Yes

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

K191843

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

8d34678f-ecd6-426a-acba-577ac8050dd0

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

October 28, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-