Duns Number:201637158
Device Description: PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodo PeriAcryl® is indicated to be used as an adjunct to temporarily assist in securing periodontal dressings.
Catalog Number
P-ACRYLU(V)
Brand Name
PeriAcryl®
Version/Model Number
P-ACRYLU(V)
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
K071484,K071484
Product Code
EMA
Product Code Name
Cement, Dental
Public Device Record Key
99ed951b-c835-4c63-9ac8-9dff525ae5de
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
February 06, 2017
Package DI Number
D795013
Quantity per Package
12
Contains DI Package
D795010
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |