# K182246: Mist IC

- Pathway: 510(k) (Traditional)
- Applicant: Imagine Milling Technologies, LLC
- Decided: Apr 16, 2019 after 239 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 317 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 322 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 4.

## Most influential descendants
- K222368: Mist IC (2022), 2 descendants of its own
- K243009: Mist IC (2025), 1 descendant of its own
- K261122: Mist IC (2026), 0 descendants of its own
- K242978: Geo Abutment (2025), 0 descendants of its own

## Indications for use
MIST IC abutments are intended for use to support a prosthetic device in a partially or completely edentulous patient. They are intended to support a single-unit or multi-unit, cement-retained prosthesis in the mandible or maxilla. MIST IC abutments are compatible for use with the following implants: Keystone Dental Implant Line Platform Diameter (mm) Body Diameter (mm) Genesis 3.8, 4.5, 5.5, 6.5 3.8, 4.5, 5.5, 6.5 PrimaConnex® 1.0 (Straight) 3.5, 4.1, 5.0 3.3, 4.0, 5.0 PrimaConnex® 1.0 (Tapered) 3.5, 4.1, 5.0 3.5, 4.1, 5.0 All digitally designed custom abutments for use with MIST IC abutments are to be sent to an Imagine Milling Technologies validated milling center for manufacture.

Source page: https://510kreport.com/device/K182246
Methodology: https://510kreport.com/methodology