Catalog Number

E15 L

Brand Name

EXPERTmatic E15 L

Version/Model Number

1.007.5530

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K073478

Product Code

EFB

Product Code Name

HANDPIECE, AIR-POWERED, DENTAL

Public Device Record Key

531e33b4-63be-4b70-a720-8ce4df560f9b

Public Version Date

November 08, 2021

Public Version Number

6

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-