Catalog Number

-

Brand Name

Dentek

Version/Model Number

00027701203G

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OBR

Product Code Name

Mouthguard, Over-The-Counter

Public Device Record Key

7d17e193-f87b-44e6-8031-d28ad690fd5a

Public Version Date

July 22, 2020

Public Version Number

1

DI Record Publish Date

July 14, 2020

Package DI Number

50047701002778

Quantity per Package

1

Contains DI Package

00047701002773

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single