Duns Number:341575872
Device Description: DentalDB is a software application intended for the management of data regarding patients, DentalDB is a software application intended for the management of data regarding patients, cases, dental practices, dentallaboratories, and manufacturing facilities. The optional dentalshare service allows for the transfer of pertinent data to andfrom remote facilities.DentalDB is intended for use by trained professionals, such as dental technicians and dentists.
Catalog Number
-
Brand Name
DentalDB
Version/Model Number
2.1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
February 19, 2023
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
-
Product Code
OUG
Product Code Name
Medical Device Data System
Public Device Record Key
041f50b3-ffa4-44c9-b37c-3ba5490706fc
Public Version Date
September 24, 2018
Public Version Number
3
DI Record Publish Date
February 20, 2018
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 |