Catalog Number

-

Brand Name

DENTA II

Version/Model Number

DENTA II body

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091320,K091320

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

138d329d-7dd4-43d2-986c-83d925d9c642

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 13, 2016

Package DI Number

8809447651514

Quantity per Package

1

Contains DI Package

08809447651507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton case