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 |