The following data is part of a premarket notification filed by Biomaterials Korea, Inc with the FDA for Anchor Plate.
| Device ID | K173623 |
| 510k Number | K173623 |
| Device Name: | Anchor Plate |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | BioMaterials Korea, Inc #413, #329, #331 150, Jojeong-daero Hanam-si, KR 12930 |
| Contact | Jiyea Kim |
| Correspondent | Jiyea Kim Regulatory Insight, Inc #413, #329, #331 150, Jojeong-daero, Hanam-si Gyeonggi-do, KR 12930 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-24 |
| Decision Date | 2018-08-30 |
| Summary: | summary |