Catalog Number

-

Brand Name

Permanent Crown C2

Version/Model Number

FLPCC201US

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K201668,K201668

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

9a0a4722-79aa-4ff9-914b-88bfc4c91bf7

Public Version Date

September 15, 2021

Public Version Number

3

DI Record Publish Date

October 19, 2020

Package DI Number

EBGOFLPCC201US2

Quantity per Package

1

Contains DI Package

EBGOFLPCC201US1

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box