The following data is part of a premarket notification filed by Imagine Milling Technologies, Llc with the FDA for Mist Ic.
| Device ID | K182246 |
| 510k Number | K182246 |
| Device Name: | MIST IC |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Imagine Milling Technologies, LLC 14225-E Sullyfield Circle Chantilly, VA 20151 |
| Contact | Felix Chung |
| Correspondent | Kevin A. Thomas 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 | 2018-08-20 |
| Decision Date | 2019-04-16 |