The following data is part of a premarket notification filed by Implant Solutions Pty Ltd (osteon Medical) with the FDA for Osteon Precision Milled Suprastructure.
| Device ID | K212676 |
| 510k Number | K212676 |
| Device Name: | Osteon Precision Milled Suprastructure |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Implant Solutions PTY LTD (Osteon Medical) 759-767 Springvale Road Mulgrave, AU 3170 |
| Contact | Andrea Del Ciotto |
| Correspondent | Melissa Burbage PaxMed International, LLC 12264 EL Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-24 |
| Decision Date | 2022-03-03 |