Duns Number:123314076
Device Description: Gro3X DIU system is an optical impression system used to record the topographical characte Gro3X DIU system is an optical impression system used to record the topographical characteristics of teeth, dental impressions, or stone models for use in the computer aided design and manufacturing of dental restorative prosthetic devices. Gro3X DIU system consists of a handheld scanner with base, tips (reusable upon autoclave), cables and software.
Catalog Number
-
Brand Name
Gro3X DIU
Version/Model Number
DIU-3D-71-001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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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
NOF
Product Code Name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Public Device Record Key
e1da7423-4f88-456d-89fe-dd2cbc4de59c
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
May 20, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |