Catalog Number

-

Brand Name

NA

Version/Model Number

BBBT11.5

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)

-

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

K020617

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

d7c84c77-71c1-4902-a8ff-3bc8b52a433a

Public Version Date

September 05, 2022

Public Version Number

2

DI Record Publish Date

January 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-