Catalog Number

150-102B

Brand Name

Health-Tec Bite Registration Material

Version/Model Number

150-102B

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

K041028,K041028

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

115eaa9d-e42e-4a32-82c2-463331ff1c90

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-