FDA product code NFS: Device, Jaw Tracking, For Monitoring Jaw Positions
NFS is the FDA product code for device, jaw tracking, for monitoring jaw positions. It is a Class I device, regulated under 21 CFR 872.2060 and reviewed by the Dental panel. FDA has cleared 2 510(k) submissions under NFS, from 2 different applicants. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Device, Jaw Tracking, For Monitoring Jaw Positions |
| Device class | Class I |
| Regulation | 21 CFR 872.2060 |
| Review panel | DE — Dental |
| Medical specialty | Dental |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NFS clearance
Top NFS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio-Research Associates, Inc. | 1 | 1995-09-21 |
| Siemens Medical Solutions USA, Inc. | 1 | 1984-11-14 |
Most recent NFS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K952218 | Bio-Research Associates, Inc. | JT-3 ELECTROGNATHOGRAPH | 1995-09-21 | 133 |
| K843951 | Siemens Medical Solutions USA, Inc. | SIROGNATHOGRAPH | 1984-11-14 | 36 |
Recalls for NFS devices
openFDA lists no recalls for product code NFS.
Frequently asked questions
What is FDA product code NFS?
NFS is the FDA product code for device, jaw tracking, for monitoring jaw positions. It is a Class I device, regulated under 21 CFR 872.2060 and reviewed by the Dental panel.
What device class is NFS?
Class I, regulation 21 CFR 872.2060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NFS?
Across 2 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most NFS clearances?
Bio-Research Associates, Inc. (1); Siemens Medical Solutions USA, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NFS
- Run a recall and safety report across every NFS manufacturer
- Watch product code NFS 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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