The following data is part of a premarket notification filed by Biomaterials Korea Inc. with the FDA for C Type, Ct Type, And Special Type Orthodontic Anchor Screws.
| Device ID | K063495 |
| 510k Number | K063495 |
| Device Name: | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | BIOMATERIALS KOREA INC. 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls, Rac |
| Correspondent | Kevin Walls, Rac BIOMATERIALS KOREA INC. 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-20 |
| Decision Date | 2007-07-26 |