Catalog Number

-

Brand Name

PRO3DURE THERMEO Blank

Version/Model Number

clear transparent, height 16 mm

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

-

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

K212017

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

11be1795-1609-4879-b8c1-d6ba2ece693e

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-