Catalog Number

-

Brand Name

Burkhart Bite Registration Clear HP Fast Set 50ML (2)

Version/Model Number

72720547

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

-

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

-

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

e1d4bdcd-5177-4d34-9075-6c310ee8a388

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

20815878020203

Quantity per Package

10

Contains DI Package

10815878020206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-