Catalog Number

150-101

Brand Name

Health-Tec Bite Registration Material

Version/Model Number

150-101

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,K041028

Product Code

ELW

Product Code Name

Material, Impression

Public Device Record Key

cfa5f0b8-b795-4edc-a33f-f821593c5319

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D7731501013

Quantity per Package

10

Contains DI Package

D7731501011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-