Catalog Number

4220105

Brand Name

KeySplint Soft for EnvisionTEC

Version/Model Number

4220105

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

KMY

Product Code Name

POSITIONER, TOOTH, PREFORMED

Public Device Record Key

108e3cb6-2e7c-4f87-8519-0c54f522c794

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 06, 2021

Package DI Number

H66842201052

Quantity per Package

8

Contains DI Package

H66842201051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box