The following data is part of a premarket notification filed by Truabutment with the FDA for Truabutment Ds.
| Device ID | K170259 |
| 510k Number | K170259 |
| Device Name: | TruAbutment DS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | TRUABUTMENT 300 SOUTH HARBOR BLVD #520 Anaheim, CA 92805 |
| Contact | Brandon Kim |
| Correspondent | April Lee WITHUS GROUP INC 2531 PEPPERDALE DRIVE Rowland Heights, CA 91748 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-27 |
| Decision Date | 2017-05-25 |
| Summary: | summary |