Catalog Number

64-2015-1100

Brand Name

BioBite

Version/Model Number

64-2015-1100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

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

-

Product Code

DYJ

Product Code Name

RETAINER, SCREW EXPANSION, ORTHODONTIC

Public Device Record Key

326c9a3a-17e2-46f1-a485-5bc3220888cf

Public Version Date

August 10, 2022

Public Version Number

2

DI Record Publish Date

September 14, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-