Class Class II
MIST IC (K243009)
Description
MIST IC by Imagine Milling Technologies, LLC, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243009
Clearance Date2025-06-24
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243009
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. MIST IC (K243009) cites 6 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K240208 | DESS Dental Smart Solutions | Terrats Medical SL | 2024 |
| K222368 | MIST IC | Imagine Milling Technologies, LLC | 2022 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materi... | 2020 |
| K182246 | MIST IC | Imagine Milling Technologies, LLC | 2019 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap ... | Straumann USA, LLC | 2017 |
| K022476 | RELYX RMGIP | 3M Company | 2002 |
Trace the full predicate network for K243009
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.