The following data is part of a premarket notification filed by Lancer Orthodontics, Inc. with the FDA for O.a.s.i. System.
| Device ID | K051552 |
| 510k Number | K051552 |
| Device Name: | O.A.S.I. SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | LANCER ORTHODONTICS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Contact | Grace Holland |
| Correspondent | Grace Holland LANCER ORTHODONTICS, INC. 3722 AVE. SAUSALITO Irvine, CA 92606 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-09-19 |
| Summary: | summary |