# K261122: Mist IC

- Pathway: 510(k) (Traditional)
- Applicant: Imagine Milling Technologies, LLC
- Decided: Jun 27, 2026 after 85 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: 19 generations back to K960026 (1996). 320 ancestors in all.
No later device cites it as a predicate yet.
0 of 321 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243009: Mist IC, Imagine Milling Technologies, LLC (2025) Summary page 5.

## 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: Compatible Implant Line Implant Body Diameter, mm Prosthetic Connection, mm 3.4 3.3 SICace 4.0 (Internal hex) 4.5 4.2 5.0 3.7 3.3 SICmax 4.2 (Internal hex) 4.7 4.2 5.2 3.7 3.3 SICtapered 4.2 (Internal hex) 4.7 4.2 5.2 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/K261122
Methodology: https://510kreport.com/methodology