Catalog Number

855-295

Brand Name

Bondable Retainer

Version/Model Number

855-295

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 31, 2022

Issuing Agency

In GS1

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

-

Product Code

DYT

Product Code Name

MAINTAINER, SPACE PREFORMED, ORTHODONTIC

Public Device Record Key

bb5a1c1c-6c34-43d3-b23e-2e400bc43f08

Public Version Date

February 01, 2022

Public Version Number

3

DI Record Publish Date

June 24, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-