Duns Number:006309355
Device Description: Denticator Tip-A-Dent - Angled interproximal brush & Angled gum stimulator
Catalog Number
621814
Brand Name
Denticator
Version/Model Number
621814
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)
Yes
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
JET
Product Code Name
PICK, MASSAGING
Public Device Record Key
58bef352-56c6-4e80-9634-fbfccf21642c
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 16, 2022
Package DI Number
20302736218143
Quantity per Package
25
Contains DI Package
00302736218149
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 138 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |