Duns Number:012430880
Device Description: ACCLEAN ONE STEP FLUORIDE VARNISH BUBBLE GUM -200ct
Catalog Number
5700523
Brand Name
Henry Schein
Version/Model Number
5700523
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"
Yes
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
LBH
Product Code Name
VARNISH, CAVITY
Public Device Record Key
83deb6e8-b746-45e9-96b4-e37c1fc8a173
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
February 14, 2017
Package DI Number
10304040040499
Quantity per Package
8
Contains DI Package
00304040040492
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 |