Duns Number:005473608
Device Description: Saliva-Check Mutans Kit, (10) test kits wich include: 1 Mutans Test Device, 1 paraffin Gu Saliva-Check Mutans Kit, (10) test kits wich include: 1 Mutans Test Device, 1 paraffin Gum, 1 Pipette, 1 Mixing Container, 1 bottle of Reagent #1 (2mL) and 1 bottle of Reagent #2 (4mL)
Catalog Number
004504
Brand Name
Saliva-Check
Version/Model Number
004504
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 16, 2018
Issuing Agency
In HIBCC
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
Yes
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
EGD
Product Code Name
WAX, DENTAL, INTRAORAL
Public Device Record Key
ae5f51f6-a582-458f-9681-ebbe7f6982af
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 24, 2017
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4772 |