Catalog Number

PCSD95

Brand Name

The Original Clearsplint Disc

Version/Model Number

PCSD95

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

K111828

Product Code

MQC

Product Code Name

Mouthguard, Prescription

Public Device Record Key

7177e2f1-9fc6-4806-8a97-2079c3c6767e

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-