The following data is part of a premarket notification filed by Aeon Astron Europe B.v. with the FDA for Aongen Dental Collagen Matrix.
| Device ID | K112568 |
| 510k Number | K112568 |
| Device Name: | AONGEN DENTAL COLLAGEN MATRIX |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 Leiden, NL 2333 Ca |
| Contact | Horng Ji Lai |
| Correspondent | Horng Ji Lai AEON ASTRON EUROPE B.V. NIELS BOHRWEG 11-13 Leiden, NL 2333 Ca |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-06 |
| Decision Date | 2012-03-01 |
| Summary: | summary |