The following data is part of a premarket notification filed by Implant Direct Sybron Manufacturing, Llc with the FDA for Custom Bars.
| Device ID | K162633 |
| 510k Number | K162633 |
| Device Name: | Custom Bars |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | IMPLANT DIRECT SYBRON MANUFACTURING, LLC 3050 EAST HILLCREST DRIVE Thousand Oaks, CA 91362 |
| Contact | Reina Choi |
| Correspondent | Reina Choi IMPLANT DIRECT SYBRON MANUFACTURING, LLC 3050 EAST HILLCREST DRIVE Thousand Oaks, CA 91362 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-21 |
| Decision Date | 2017-07-24 |
| Summary: | summary |