The following data is part of a premarket notification filed by Biomaterials Korea Inc. with the FDA for Sl Type Orthodontic Anchor Screws, Spl Type Orthodontic Anchor Screws.
| Device ID | K111809 |
| 510k Number | K111809 |
| Device Name: | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | BIOMATERIALS KOREA INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls BIOMATERIALS KOREA INC. 5401 S. COTTONWOOD CT. Greenwood Village, CO 80121 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-27 |
| Decision Date | 2011-09-26 |
| Summary: | summary |