MIST IC— 510(k) K261122
Substantially EquivalentImagine Milling Technologies, LLC
FDA 510(k) clearance K261122 for MIST IC, Substantially Equivalent on 2026-06-27. Applicant: Imagine Milling Technologies, LLC. Device class: 2.
Summary
MIST IC from Imagine Milling Technologies is filed under NHA, endosseous dental implant abutments. The record doesn't expand the name or list models.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Imagine Milling filed from Chantilly, Virginia. Review took 85 calendar days (April 3 to June 27, 2026).
Clearance details
- Applicant
- Imagine Milling Technologies, LLC
- Product code
- Product code NHA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3630
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chantilly, VA, US
Recent devices under product code NHA
view allMore clearances from Imagine Milling Technologies, LLC
view allAdverse events under product code NHA
product code NHA- Injury
- 1,270
- Malfunction
- 2,860
- Total
- 4,130
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.