The following data is part of a premarket notification filed by Truabutment Inc. with the FDA for Truabutment Ds, Trubase.
| Device ID | K213961 |
| 510k Number | K213961 |
| Device Name: | TruAbutment DS, TruBase |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | TruAbutment Inc. 17666 Fitch Irvine, CA 92614 |
| Contact | Hyeonhwa An |
| Correspondent | Chris Choi TruAbutment Inc. 17666 Fitch Irvine, CA 92614 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-20 |
| Decision Date | 2022-07-14 |