Catalog Number

DT-113HF

Brand Name

AIR-FLOW

Version/Model Number

b

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

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

K092289,K092289

Product Code

EFB

Product Code Name

Handpiece, Air-Powered, Dental

Public Device Record Key

e53da07a-3193-4b84-b602-9ffab6e52b26

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

07613353002435

Quantity per Package

4

Contains DI Package

07613353002374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-