Duns Number:483599259
Device Description: Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 Emdogain 0.3 ml Multipack USA, contains 3 syringes Emdogain 0.3 ml, 3 syringes PrefGel 0.6 ml and 6 blunt needles
Catalog Number
075.113
Brand Name
Emdogain
Version/Model Number
1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 18, 2021
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
P930021
Product Code
NQA
Product Code Name
Biologic Material, Dental
Public Device Record Key
3f69de60-ec62-4cef-b3b6-fd5606be2dc5
Public Version Date
November 23, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2014
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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |