Elos Accurate Hybrid Base— 510(k) K261327
Substantially EquivalentElos Medtech Pinol A/S
FDA 510(k) clearance K261327 for Elos Accurate Hybrid Base, Substantially Equivalent on 2026-09-30. Applicant: Elos Medtech Pinol A/S. Device class: 2.
Summary
The Elos Accurate Hybrid Base is a dental implant component, filed under NHA, endosseous dental implant abutments. That code covers components used with an endosseous implant fixture to aid prosthetic rehabilitation. The record doesn't describe what "Hybrid Base" means for this design or which implant systems it fits.
Class II, 21 CFR 872.3630, reviewed by the Dental panel as a Traditional 510(k).
Elos Medtech Pinol A/S filed from Goerloese, Denmark. The review clock ran 161 days, from April 22 to September 30, 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.