Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue— 510(k) K260460
Substantially EquivalentInstitut Straumann AG
FDA 510(k) clearance K260460 for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue, Substantially Equivalent on 2026-05-07. Applicant: Institut Straumann AG. Device class: 2.
Summary
Institut Straumann's record covers Neodent Gold Hue Custom Abutments and Medentika Custom Abutments Gold Hue. The product code is NHA, endosseous dental implant abutments.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel, and it was a Traditional 510(k).
The record spells the city Basal, Switzerland. The decision came 85 calendar days after receipt (February 11 to May 7, 2026).
Clearance details
- Applicant
- Institut Straumann AG
- 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
- Basal, CH
Recent devices under product code NHA
view allMore clearances from Institut Straumann AG
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.