Catalog Number

-

Brand Name

Restoration, Resin: Nightguard, Splint

Version/Model Number

Not Applicable

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

NSR

Product Code Name

Prosthesis, Orthodontic

Public Device Record Key

0861bf44-e6b8-42f5-8b03-a8c7b7999675

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-