Catalog Number

D1E4

Brand Name

n/a

Version/Model Number

D1E4

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132315

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

13e3c4da-8d0c-4201-b084-27a1a0721c8b

Public Version Date

October 31, 2022

Public Version Number

2

DI Record Publish Date

September 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-