Catalog Number

-

Brand Name

CROWN PX

Version/Model Number

T61S, B4

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

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

K060507

Product Code

ELM

Product Code Name

Denture, Plastic, Teeth

Public Device Record Key

74a72951-f8a3-4325-b2c8-e5471cb442ca

Public Version Date

June 19, 2020

Public Version Number

1

DI Record Publish Date

June 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-