Elos Accurate® Denture Fixation System— 510(k) K253774
Substantially EquivalentElos Medtech Pinol A/S
FDA 510(k) clearance K253774 for Elos Accurate® Denture Fixation System, Substantially Equivalent on 2026-05-20. Applicant: Elos Medtech Pinol A/S. Device class: 2.
Summary
Elos Medtech Pinol's Elos Accurate Denture Fixation System is filed under NHA, endosseous dental implant abutments.
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).
Elos filed from Goerloese, Denmark. The decision came 175 calendar days after receipt (November 26, 2025 to May 20, 2026).
Clearance details
- Applicant
- Elos Medtech Pinol A/S
- 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
- Goerloese, DK
Recent devices under product code NHA
view allMore clearances from Elos Medtech Pinol A/S
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.