The following data is part of a premarket notification filed by Innocoll Pharmaceuticals with the FDA for Collacare Dental.
| Device ID | K133290 |
| 510k Number | K133290 |
| Device Name: | COLLACARE DENTAL |
| Classification | Dressing, Wound, Collagen |
| Applicant | INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
| Contact | Aaron Wyse |
| Correspondent | Aaron Wyse INNOCOLL PHARMACEUTICALS DUBLIN ROAD Athlone, Co. Westmeath, IE |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-25 |
| Decision Date | 2014-05-01 |
| Summary: | summary |