The following data is part of a premarket notification filed by Ids - Integrated Dental Systems with the FDA for Reflect Implant System.
Device ID | K180924 |
510k Number | K180924 |
Device Name: | Reflect Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | ids - Integrated Dental Systems 300 Sylvan Ave. Suite 104 Englewood Cliffs, NJ 07632 |
Contact | Elizabeth Marrero |
Correspondent | Floyd Larson PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, CA 92130 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-04-09 |
Decision Date | 2019-03-29 |