Catalog Number

-

Brand Name

OrthoEasy®

Version/Model Number

1201A2308

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

K110275,K110275

Product Code

OAT

Product Code Name

Implant, endosseous, orthodontic

Public Device Record Key

fe7f5775-5a5a-45cd-9ef8-62f983ccba53

Public Version Date

August 23, 2019

Public Version Number

1

DI Record Publish Date

August 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-