Catalog Number

-

Brand Name

CORE1 Fixture

Version/Model Number

C1M3511SC

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K210039

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

2c2415f6-0f69-4a66-97bd-32d307b781a7

Public Version Date

March 30, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-