Catalog Number

10501

Brand Name

SICAT OPTIMOTION

Version/Model Number

10501

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

K143655

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

470273c5-bf67-40c9-ac70-47ba9be8103f

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-