Duns Number:012430880
Device Description: Simple, effective way of maintaining clean dental unit waterlines. Simply add one tablet t Simple, effective way of maintaining clean dental unit waterlines. Simply add one tablet to your units water bottle, each time it is refilled, for continuous treatment. Tasteless, odorless, and has no affect on bonding. EPA registered to provide less than or equal to 10 CFU/mL. One tablet treats 700750 mL.
Catalog Number
5702561
Brand Name
Henry Schein
Version/Model Number
5702561
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
Yes
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
NRD
Product Code Name
Unit, operative dental, accessories
Public Device Record Key
524169c5-4844-4428-a3c3-76fa5c84e09e
Public Version Date
March 24, 2021
Public Version Number
1
DI Record Publish Date
March 16, 2021
Package DI Number
20304040151741
Quantity per Package
12
Contains DI Package
10304040151744
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |