Product code NHA: 510(k) clearances and predicates
Product code NHA covers Cemented Plus Abutment. FDA lists 715 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
715 clearances on file under product code NHA. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 33 |
| 2023 | 51 |
| 2024 | 43 |
| 2025 | 40 |
| 2026 so far | 22 |
Recent clearances
Newest NHA clearances in the FDA index, with applicant and decision date:
- K262207, Cemented Plus Abutment, applicant Unidental Co., Ltd., decided 2026-09-23. FDA record
- K260940, BellaTek Bars, applicant ZimVie US Corp, LLC, decided 2026-09-21. FDA record
- K253999, Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw, applicant Nobel Biocare AB, decided 2026-08-06. FDA record
- K261147, Neodent Implant System - NeoConvert Fit, applicant JJGC Indústria e Comércio de Materiais Dentários S.A., decided 2026-07-01. FDA record
- K261122, MIST IC, applicant Imagine Milling Technologies, LLC, decided 2026-06-27. FDA record
- K260061, BioHorizons CEREC Compatible Ti-Bases, applicant BioHorizons Implant Systems, Inc., decided 2026-06-26. FDA record
- K253922, Neodent Scannable Healing Abutment, applicant JJGC Indústria e Comércio de Materiais Dentários S.A., decided 2026-06-15. FDA record
- K254145, Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut), applicant Smart Denture Conversions, LLC, decided 2026-06-11. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include BellaTek Bars, Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw. Watch new NHA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code NHA?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent NHA clearances include Cemented Plus Abutment.
How many 510(k) clearances use product code NHA?
715 at the time this page was generated, from openFDA records.
How do I find a predicate device under NHA?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new NHA clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.