Catalog Number

150-102

Brand Name

Health-Tec Bite Registration Material

Version/Model Number

150-102

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Conditional

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

d4af829f-4937-42e9-8493-1b92bed4f5b0

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 24, 2017

Package DI Number

D7731501023

Quantity per Package

10

Contains DI Package

D7731501021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-