Catalog Number

-

Brand Name

NA

Version/Model Number

HA-L-35W-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

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

K070905

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

936eb51d-c53c-4e1d-84dd-0afac62cbfda

Public Version Date

September 05, 2022

Public Version Number

2

DI Record Publish Date

January 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-