The following data is part of a premarket notification filed by Elegant Dental Corp. with the FDA for Duranext Abutments.
| Device ID | K200355 |
| 510k Number | K200355 |
| Device Name: | Duranext Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Elegant Dental Corp. 2308 McDonald Avenue Brooklyn, NY 11223 |
| Contact | Gary Fingerman |
| Correspondent | Floyd G Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-13 |
| Decision Date | 2020-07-22 |