Catalog Number

-

Brand Name

EDENTA

Version/Model Number

K900445-1000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EBL

Product Code Name

PIN, RETENTIVE AND SPLINTING, AND ACCESSORY INSTRUMENTS

Public Device Record Key

fe6dfa74-ea16-43c8-8335-c7ec3df95f96

Public Version Date

February 11, 2022

Public Version Number

1

DI Record Publish Date

February 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-