Catalog Number

659740V

Brand Name

Palodent® V3 Sectional Matrix System

Version/Model Number

659740V

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"

Yes

For Single-Use

Yes

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

DZN

Product Code Name

INSTRUMENTS, DENTAL HAND

Public Device Record Key

b834577f-db7e-4342-9902-6d7c6b1dfdc3

Public Version Date

August 24, 2022

Public Version Number

1

DI Record Publish Date

August 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-