FDA · official record K254145Substantially Equivalent

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)

Name: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) — FDA K254145
Creator: Smart Denture Conversions, LLC
Keywords: Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™), Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™), K254145, NHA, FDA

United StatesNHASmart Denture Conversions, LLC

Verified

Official record identity

FDA application number: K254145
Decision date: June 11, 2026
Published decision: Substantially Equivalent

Classification

Product code: NHA

Published parties

Applicant: Smart Denture Conversions, LLC

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Abbreviated
Received date: 2025-12-22
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3630

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.