FDA product code · Dental · Class 2
NHA: Abutment, Implant, Dental, Endosseous
NHA is FDA's product code for "Abutment, Implant, Dental, Endosseous": a Class 2 device classified under 21 CFR 872.3630, reviewed by the Dental panel. FDA flags it as an implant.
510(k) review time for NHA
Across 315 510(k) clearances under NHA decided from 2018-01-01 to 2026-10-06, the median was 163 days from FDA receipt to decision. Half took between 98 and 246 days, and 80% were decided within 265 days. These are past clearances, not a forecast for a new submission.
| Fastest | 20 |
|---|---|
| 25th percentile | 98 |
| Median | 163 |
| 75th percentile | 246 |
| 80th percentile | 265 |
| 90th percentile | 333 |
| Slowest | 1,356 |
| Year | Median days | n |
|---|---|---|
| 2018 | 200 | 31 |
| 2019 | 160 | 28 |
| 2020 | 153 | 38 |
| 2021 | 211 | 29 |
| 2022 | 142 | 33 |
| 2023 | 147 | 51 |
| 2024 | 158 | 43 |
| 2025 | 147 | 40 |
| 2026 (to 10-06, partial) | 170 | 22 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
NHA in the public FDA record
| 510(k) clearances, all years | 713 |
|---|---|
| Device recalls | 225 |
| Establishment listings | 2,608 |
| GUDID device identifiers | 101,734 |
Counts of records, not of devices or events. Adverse event reports for NHA are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite NHA
6 FDA recognized consensus standards cite NHA, 1 of them recognized only in part, among them ISO 10993-14 First edition 2001-11-15; ISO 14801 Third edition 2016-11-01; ANSI ADA Technical Report No. 146-2018. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 2-170 ISO 10993-14 First edition 2001-11-15 — Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
- 4-259 ISO 14801 Third edition 2016-11-01 (partial recognition) — Dentistry - Implants - Dynamic loading test for endosseous dental implants
- 4-270 ANSI ADA Technical Report No. 146-2018 — CAD/CAM Abutments in Dentistry
- 4-338 ISO 22683 First edition 2022-05 — Dentistry - Rotational adaptability test between implant body and implant abutment in dental implant systems
- 4-391 ISO 16498 First edition 2013-07 — Dentistry - Minimal dental implant data set for clinical use
- 8-226 ASTM F603-12 (Reapproved 2020) — Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.