The following data is part of a premarket notification filed by Terrats Medical Sl with the FDA for Dess Dental Smart Solutions.
Device ID | K191986 |
510k Number | K191986 |
Device Name: | DESS Dental Smart Solutions |
Classification | Abutment, Implant, Dental, Endosseous |
Applicant | Terrats Medical SL Carrer Mogoda 75-99 Barbera Del Valles, ES 08210 |
Contact | Roger Terrats |
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 | 2019-07-25 |
Decision Date | 2019-11-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DESS DENTAL SMART SOLUTIONS 79152723 4737208 Live/Registered |
TERRATS GROUP, S.L. 2014-06-18 |