Catalog Number

102-3888

Brand Name

Nice-Temp™ Temporary Material

Version/Model Number

102-3888

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

-

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

EBG

Product Code Name

CROWN AND BRIDGE, TEMPORARY, RESIN

Public Device Record Key

e0eb9207-c57c-432e-82d0-1183d2a39ead

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

February 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-