Catalog Number

1016233

Brand Name

Polystar Selection EDITION anteriors for Ceramill FDS of Amann Girrbach

Version/Model Number

anteriors; shade BL3; mould UM4

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

K030588

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

3cc2097d-6421-4846-836d-479699ec95db

Public Version Date

December 13, 2021

Public Version Number

2

DI Record Publish Date

October 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-