Catalog Number

1312036

Brand Name

TRI-TAPERED

Version/Model Number

1312036

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"

-

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

K103790

Product Code

NHA

Product Code Name

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Public Device Record Key

74bddd26-462c-4d92-90e0-691094fa90bf

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 12, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-