Solidex® Ti-Links and Screws— 510(k) K251515
Substantially EquivalentCreoDent Hudson Valley
FDA 510(k) clearance K251515 for Solidex® Ti-Links and Screws, Substantially Equivalent on 2026-02-10. Applicant: CreoDent Hudson Valley. Device class: 2.
Summary
CreoDent Hudson Valley's Solidex® Ti-Links and Screws are filed under product code NHA (Abutment, Implant, Dental, Endosseous). The record doesn't describe them beyond the name and that code name.
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).
CreoDent Hudson Valley filed from Fishkill, New York. The substantially equivalent decision came 270 calendar days after receipt (May 16, 2025 to February 10, 2026).
Clearance details
- Applicant
- CreoDent Hudson Valley
- 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
- Fishkill, NY, US
Recent devices under product code NHA
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.