Catalog Number

1030010

Brand Name

PremEco Line Prothetik Color System

Version/Model Number

Refill: colour opal 8g

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

K130076

Product Code

EBI

Product Code Name

Resin, Denture, Relining, Repairing, Rebasing

Public Device Record Key

256590c5-111f-4bd7-8845-8fe3588f3091

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

July 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-