Catalog Number

-

Brand Name

A-dec

Version/Model Number

11.0232.80

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K000968

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

0e4ac014-5924-408b-8ab2-5dd24a6909f3

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-