The following data is part of a premarket notification filed by Ortho Organizers, Inc. with the FDA for Ortho Organizers Temporary Orthodontic Anchor.
| Device ID | K061266 |
| 510k Number | K061266 |
| Device Name: | ORTHO ORGANIZERS TEMPORARY ORTHODONTIC ANCHOR |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | ORTHO ORGANIZERS, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson ORTHO ORGANIZERS, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-05 |
| Decision Date | 2006-07-31 |
| Summary: | summary |