Duns Number:002863526
Device Description: PAA Tooth Conditioner Filled & Labeled 15 ml Bottle Kit
Catalog Number
-
Brand Name
PAA Tooth Conditioner
Version/Model Number
675BOT150
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K895386
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
7ce0f586-2af2-47f2-8f27-3cbeea5a2393
Public Version Date
August 29, 2019
Public Version Number
2
DI Record Publish Date
June 10, 2019
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |
| U | Unclassified | 5 |