Catalog Number

-

Brand Name

NA

Version/Model Number

DCT3013

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

K163060

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

b12c5044-6808-42d8-98c9-0e9bb6ee0e26

Public Version Date

September 13, 2022

Public Version Number

2

DI Record Publish Date

December 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-