Catalog Number

179140-HLD

Brand Name

Heldent

Version/Model Number

Scanner

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 25, 2020

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

-

Product Code

NOF

Product Code Name

System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

Public Device Record Key

b92375d5-62f2-4921-88f2-ee535d25ac98

Public Version Date

February 21, 2022

Public Version Number

3

DI Record Publish Date

September 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-