The following data is part of a premarket notification filed by Bio Cetec Co., Ltd. with the FDA for Bio-tacks Orthodontic Mini Implant.
| Device ID | K190871 |
| 510k Number | K190871 |
| Device Name: | Bio-TackS Orthodontic Mini Implant |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | Bio Cetec Co., Ltd. RM 1001-1002 New T Castle, 108, Gasan Digital 2-ro Geumcheon-gu Seoul, KR 08506 |
| Contact | Hee Sue Jin |
| Correspondent | Dave Kim MTech Group Inc. 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-03 |
| Decision Date | 2020-01-17 |