Catalog Number

LN2-014

Brand Name

Horizon Mini Twin Bracket System

Version/Model Number

.018 ROTH HIGH TORQUE

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

-

Product Code

EJF

Product Code Name

Bracket, Metal, Orthodontic

Public Device Record Key

85df44f8-c5c0-43c0-8163-aef371d2c1a0

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-