Catalog Number

-

Brand Name

Orthocryl®

Version/Model Number

161-227-00

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

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

K942667

Product Code

KMY

Product Code Name

POSITIONER, TOOTH, PREFORMED

Public Device Record Key

c46159f7-40df-4e50-92a5-51afe2103f32

Public Version Date

October 21, 2022

Public Version Number

6

DI Record Publish Date

December 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-