The following data is part of a premarket notification filed by Osteomed L.p. with the FDA for Osteomed Orthodontic Screw System.
| Device ID | K031936 |
| 510k Number | K031936 |
| Device Name: | OSTEOMED ORTHODONTIC SCREW SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Contact | Dawn T Holdeman |
| Correspondent | Dawn T Holdeman OSTEOMED L.P. 3885 ARAPAHO RD. Addison, TX 75001 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2004-01-07 |
| Summary: | summary |