INOSS System— 510(k) K260006
Substantially EquivalentInosys, Inc.
FDA 510(k) clearance K260006 for INOSS System, Substantially Equivalent on 2026-06-17. Applicant: Inosys, Inc.. Device class: 2.
Summary
The INOSS System from Inosys is filed under DZE, root-form endosseous implants. The record doesn't expand the name or list implant sizes or components.
Class II, 21 CFR 872.3640. Dental is both the classification panel and the review panel. The submission was a Traditional 510(k).
Inosys filed from New York, New York. The decision came 166 calendar days after FDA received it (January 2 to June 17, 2026).
Clearance details
- Applicant
- Inosys, Inc.
- Product code
- Product code DZE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3640
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code DZE
view allAdverse events under product code DZE
product code DZE- Death
- 28
- Injury
- 3,367,041
- Malfunction
- 19,958
- Other
- 13
- Total
- 3,387,040
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.