# K222368: Mist IC

- Pathway: 510(k) (Traditional)
- Applicant: Imagine Milling Technologies, LLC
- Decided: Dec 1, 2022 after 118 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: 17 generations back to K960026 (1996). 318 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 321 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182246: Mist IC, Imagine Milling Technologies, LLC (2019) Summary page 5.

## Most influential descendants
- K243009: Mist IC (2025), 1 descendant of its own
- K261122: Mist IC (2026), 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: Compatible Implant Systems Implant Body Diameter, mm Implant Platform, mm 3.25 3.4 4.0 4.1 Biomet 3i OSSEOTITE® Certain® 5.0 5.0 6.0 6.0 3.5 3.5 (NP) NobelActive® 4.3, 5.0 3.9 (RP) (conical connection) 5.5 5.1 (WP) 3.5 3.5 (NP) NobelReplace Conical Connection 4.3, 5.0 3.9 (RP) 3.75 3.5 (NP) NobelParallel Conical Connection 4.3, 5.0 3.9 (RP) 5.5 5.1 (WP) 3.5 3.5 (NP) 4.3 4.3 (RP) Replace Select Tapered TiUnite 5.0 5.0 (WP) 6.0 6.0 3.5 3.5 (NP) 4.3 4.3 (RP) Replace Select Tapered PMC 5.0 5.0 (WP) 6.0 6.0 3.5 3.5 (NP) Replace Select TC 4.0 4.3 (RP) 3.7 3.5 Zimmer Screw-Vent® 4.7 4.5 3.7, 4.1 3.5 Zimmer Tapered Screw-Vent® 4.7 4.5 6.0 5.7 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. MIST IC abutments for Biomet 3i Certain 3.25 mm implant bodies are indicated for maxillary lateral and mandibular central/lateral incisors only.

Source page: https://510kreport.com/device/K222368
Methodology: https://510kreport.com/methodology