Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut)— 510(k) K254145
Substantially EquivalentSmart Denture Conversions, LLC
FDA 510(k) clearance K254145 for Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut), Substantially Equivalent on 2026-06-11. Applicant: Smart Denture Conversions, LLC. Device class: 2.
Summary
Smart Denture Conversions' Omni-Directional Multi-Unit Abutment System, trade name Omnibut, is filed under NHA, endosseous dental implant abutments. The record gives no sizes or model numbers.
Class II, 21 CFR 872.3630. Dental is both the classification panel and the review panel. The submission was an Abbreviated 510(k).
Smart Denture Conversions filed from Apex, North Carolina. The decision came 171 calendar days after FDA received it (December 22, 2025 to June 11, 2026).
Clearance details
- Applicant
- Smart Denture Conversions, LLC
- 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
- Abbreviated
- Location
- Apex, NC, US
Recent devices under product code NHA
view allMore clearances from Smart Denture Conversions, LLC
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.