Catalog Number

-

Brand Name

Dentek

Version/Model Number

00015101203I2

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

27a19373-9011-4fea-9dfb-0b3a7ff224e5

Public Version Date

August 17, 2020

Public Version Number

1

DI Record Publish Date

August 07, 2020

Package DI Number

30050428269870

Quantity per Package

1

Contains DI Package

00050428274996

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Single