The following data is part of a premarket notification filed by G & H Wire Co. with the FDA for Orthodontic Temporary Anchorage Implant Screw.
| Device ID | K081393 |
| 510k Number | K081393 |
| Device Name: | ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | G & H WIRE CO. 11460 NORTH MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Contact | Carri Graham |
| Correspondent | Carri Graham G & H WIRE CO. 11460 NORTH MERIDIAN STREET SUITE 150 Carmel, IN 46032 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-19 |
| Decision Date | 2008-08-21 |
| Summary: | summary |