Catalog Number

210-HT30C3

Brand Name

Health-Tec MicroHybrid Composite

Version/Model Number

210-HT30C3

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 23, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EBF

Product Code Name

Material, Tooth Shade, Resin

Public Device Record Key

bc049767-decf-4aca-8001-0a1d8a248593

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-