Catalog Number

-

Brand Name

UltraPrint-Dental Temp C&B UV

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K200273

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Public Device Record Key

abbaa8b9-dfa3-497c-b2b2-99a93243256b

Public Version Date

February 14, 2022

Public Version Number

3

DI Record Publish Date

January 12, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-