Catalog Number

761248

Brand Name

Ceramill

Version/Model Number

Ceramill A-Splint 98x16

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

K191836

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

4dc50a26-739c-420d-a3af-b4f313581568

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

January 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-