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

FDA 510(k) K254145 · Smart Denture Conversions, LLC

Substantially Equivalent

510(k) numberK254145

Submission

Device name
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)
Applicant
Smart Denture Conversions, LLC
Apex, NC, US
Received
December 22, 2025
Decision date
June 11, 2026
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NHA – Abutment, Implant, Dental, Endosseous
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3630
Specialty
Dental
Implant
Yes

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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More from Institut Straumann AG

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K242064Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™)NHA · Abbreviated 01/17/2025SE

Questions and answers

When was Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) cleared by the FDA?

Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145) received a 510(k) decision of Substantially Equivalent on June 11, 2026, 171 days after the submission was received.

What is the product code of K254145?

The FDA product code is NHA – Abutment, Implant, Dental, Endosseous, a Class II (moderate risk) device regulated under 21 CFR 872.3630.