FDA product code · Dental · Class 2
NJM: Bracket, Ceramic, Orthodontic
NJM is FDA's product code for "Bracket, Ceramic, Orthodontic": a Class 2 device classified under 21 CFR 872.5470, reviewed by the Dental panel.
510(k) review time for NJM
Across 20 510(k) clearances under NJM decided from 2018-01-01 to 2026-10-06, the median was 106 days from FDA receipt to decision. Half took between 26 and 185 days, and 80% were decided within 228 days. These are past clearances, not a forecast for a new submission.
| Fastest | 1 |
|---|---|
| 25th percentile | 26 |
| Median | 106 |
| 75th percentile | 185 |
| 80th percentile | 228 |
| 90th percentile | 301 |
| Slowest | 422 |
| Year | Median days | n |
|---|---|---|
| 2019 | 200 | 6 |
| 2023 | 1 | 5 |
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.
NJM in the public FDA record
| 510(k) clearances, all years | 60 |
|---|---|
| Establishment listings | 92 |
| GUDID device identifiers | 10,288 |
Counts of records, not of devices or events. Adverse event reports for NJM 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 NJM
2 FDA recognized consensus standards cite NJM, among them ANSI ADA Standard No. 41-2020; ISO 27020 Second edition 2019-06. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-295 ANSI ADA Standard No. 41-2020 — Evaluation of Biocompatibility of Medical Devices Used in Dentistry
- 4-313 ISO 27020 Second edition 2019-06 — Dentistry - Brackets and tubes for use in orthodontics
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.