Duns Number:341575872
Device Description: The AbutmentCAD module is intended as an aid to the restoration of chewing function in par The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandiblesand maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dentallaboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybridabutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturerof an endosseous dental implant abutment to create the final device.
Catalog Number
-
Brand Name
AbutmentCAD
Version/Model Number
3.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 26, 2026
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"
-
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
K193352
Product Code
PNP
Product Code Name
Dental Abutment Design Software For Dental Laboratory
Public Device Record Key
3a35a686-466f-4831-a18f-92d35264d45d
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
October 26, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |