Catalog Number

4220004

Brand Name

KeyPrint

Version/Model Number

4220004

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

K203000,K203000

Product Code

EBI

Product Code Name

RESIN, DENTURE, RELINING, REPAIRING, REBASING

Public Device Record Key

a40841e5-b470-401c-a986-1cd6788e3fd4

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

April 22, 2021

Package DI Number

H66842200042

Quantity per Package

8

Contains DI Package

H66842200041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box