Duns Number:016649253
Device Description: Digital patient scan is used in conjunction with software and a 3D printer to build patien Digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material. Denture relining, repairing, or rebasing resin.
Catalog Number
-
Brand Name
Digital Denture
Version/Model Number
3014680794
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"
-
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
K162044
Product Code
EBI
Product Code Name
Resin, Denture, Relining, Repairing, Rebasing
Public Device Record Key
85474cc0-dab8-40c9-b956-afa0ab10a234
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
November 25, 2020
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |