The following data is part of a premarket notification filed by Dentium Co., Ltd. with the FDA for Speedy Orthodontic Screw.
| Device ID | K060500 |
| 510k Number | K060500 |
| Device Name: | SPEEDY ORTHODONTIC SCREW |
| Classification | Implant, Endosseous, Root-form |
| Applicant | DENTIUM CO., LTD. 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Contact | Cathryn N Cambria |
| Correspondent | Cathryn N Cambria DENTIUM CO., LTD. 5536 TROWBRIDGE DRIVE Dunwoody, GA 30338 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-24 |
| Decision Date | 2006-06-16 |
| Summary: | summary |