The following data is part of a premarket notification filed by Osseofuse, Inc. with the FDA for Osseofuse Dental Implant System.
| Device ID | K131748 |
| 510k Number | K131748 |
| Device Name: | OSSEOFUSE DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSEOFUSE, INC. 325 N. PUENTE ST, UNIT B Brea, CA 92821 |
| Contact | April Lee |
| Correspondent | April Lee OSSEOFUSE, INC. 325 N. PUENTE ST, UNIT B Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-14 |
| Decision Date | 2013-10-31 |
| Summary: | summary |