FDA product code NHA: Abutment, Implant, Dental, Endosseous
NHA is the FDA product code for abutment, implant, dental, endosseous. It is a Class II device, regulated under 21 CFR 872.3630 and reviewed by the Dental panel. FDA has cleared 713 510(k) submissions under NHA, 187 in the last five years, from 169 different applicants. The average 510(k) review took 169 days (median 141); 180 days on average over the last three years. FDA has posted 225 recalls for NHA devices, 24 initiated in the last five years.
Definition
To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Classification
| Field | Value |
|---|---|
| Device name | Abutment, Implant, Dental, Endosseous |
| Device class | Class II |
| Regulation | 21 CFR 872.3630 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NHA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 31 | 203 |
| 2018 | 31 | 226 |
| 2019 | 28 | 185 |
| 2020 | 38 | 179 |
| 2021 | 29 | 218 |
| 2022 | 33 | 201 |
| 2023 | 51 | 210 |
| 2024 | 43 | 182 |
| 2025 | 40 | 179 |
| 2026 | 20 | 180 |
Compare with all 510(k) review times · Search every NHA clearance
Top NHA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Institut Straumann AG | 46 | 2026-05-07 |
| Nobel Biocare AB | 42 | 2026-08-06 |
| Terrats Medical SL | 21 | 2026-06-09 |
| Zimmer Dental, Inc. | 21 | 2015-06-25 |
| Dentsply Sirona | 20 | 2025-12-09 |
164 more applicants have NHA clearances. See the full list in Caduvo.
Most recent NHA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253999 | Nobel Biocare AB | 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 | 2026-08-06 | 234 |
| K261147 | JJGC Indústria e Comércio de Materiais Dentários S.A. | Neodent Implant System - NeoConvert Fit | 2026-07-01 | 85 |
| K261122 | Imagine Milling Technologies, LLC | MIST IC | 2026-06-27 | 85 |
| K260061 | BioHorizons Implant Systems, Inc. | BioHorizons CEREC Compatible Ti-Bases | 2026-06-26 | 169 |
| K253922 | JJGC Indústria e Comércio de Materiais Dentários S.A. | Neodent Scannable Healing Abutment | 2026-06-15 | 189 |
Recalls for NHA devices
225 product recalls in 46 recall events; 24 initiated in the last five years and 24 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 4 |
| 2019 | 12 |
| 2020 | 30 |
| 2021 | 5 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 11 |
| 2026 | 5 |
Frequently asked questions
What is FDA product code NHA?
NHA is the FDA product code for abutment, implant, dental, endosseous. It is a Class II device, regulated under 21 CFR 872.3630 and reviewed by the Dental panel.
What device class is NHA?
Class II, regulation 21 CFR 872.3630. Typical premarket route: 510(k).
How long does a 510(k) take for product code NHA?
Across 713 cleared submissions the average was 169 days from receipt to decision (median 141).
Which companies have the most NHA clearances?
Institut Straumann AG (46); Nobel Biocare AB (42); Terrats Medical SL (21); Zimmer Dental, Inc. (21); Dentsply Sirona (20).
Have NHA devices been recalled?
Yes: 225 product recalls across 46 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code NHA
- Run a recall and safety report across every NHA manufacturer
- Watch product code NHA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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