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 |